A leading biotechnology firm in the UK is seeking a Regulatory Affairs Manager to oversee regulatory approvals for Phase 1 clinical trials. You will act as the Regulatory Lead, ensuring compliance with regulations and guidance, and coordinating submissions to relevant regulatory authorities. The ideal candidate has several years of regulatory experience, strong project leadership skills, and excellent communication abilities. Join us to play a pivotal role in advancing clinical research through regulatory excellence.
Jan 01, 2026
Full time
A leading biotechnology firm in the UK is seeking a Regulatory Affairs Manager to oversee regulatory approvals for Phase 1 clinical trials. You will act as the Regulatory Lead, ensuring compliance with regulations and guidance, and coordinating submissions to relevant regulatory authorities. The ideal candidate has several years of regulatory experience, strong project leadership skills, and excellent communication abilities. Join us to play a pivotal role in advancing clinical research through regulatory excellence.
Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform - "Translational Pharmaceutics " - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Why join us: Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. Summary of Job Purpose As the Regulatory Affairs Manager, you will act as Regulatory Lead, and will be responsible for obtaining regulatory (MHRA), ethics, and ARSAC approval for Phase 1 clinical trials at Quotient Sciences, and for any Phase 1/2 trials managed by the organization. You will ensure compliance with all relevant regulations and guidance, including GxP standards, and maintain a strong understanding of the regulatory framework underpinning clinical trials. Key Responsibilities Act as Regulatory Lead for cross-functional teams. Coordinate, plan, and deliver regulatory submissions, including Combined Review submissions to MHRA and ethics committees, ARSAC applications, RFIs, and amendments. Prepare, review, and quality-check key trial documents. Serve as primary contact for sponsors, MHRA, RECs, and ARSAC, negotiating practical solutions to regulatory comments. Lead regulatory discussions in sponsor and internal meetings. Advise colleagues on regulatory matters and manage urgent safety measures. Contribute to continuous quality improvement initiatives and CAPA processes. Provide training and mentorship to regulatory team members. Participate in audits and inspections by regulatory authorities. Support business development activities related to regulatory services. Maintain regulatory documentation and databases. Author and review regulatory SOPs and manage ARSAC licences. Qualifications & Experience Several years of relevant regulatory experience in a pharmaceutical company or CRO. Thorough knowledge of laws and guidance applicable to Phase 1 clinical trials. Proven ability to lead regulatory applications and submissions. Strong project leadership and teamwork skills. Excellent written and verbal communication skills. Ability to develop innovative solutions to regulatory challenges. High attention to detail and ability to manage multiple projects under tight deadlines. Job Demands High concentration and strict deadlines. Ability to juggle multiple tasks and work outside normal hours when required. Strong customer focus and responsiveness to sponsor requirements. Join Quotient Sciences and play a pivotal role in advancing clinical research through regulatory excellence. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Jan 01, 2026
Full time
Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform - "Translational Pharmaceutics " - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Why join us: Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. Summary of Job Purpose As the Regulatory Affairs Manager, you will act as Regulatory Lead, and will be responsible for obtaining regulatory (MHRA), ethics, and ARSAC approval for Phase 1 clinical trials at Quotient Sciences, and for any Phase 1/2 trials managed by the organization. You will ensure compliance with all relevant regulations and guidance, including GxP standards, and maintain a strong understanding of the regulatory framework underpinning clinical trials. Key Responsibilities Act as Regulatory Lead for cross-functional teams. Coordinate, plan, and deliver regulatory submissions, including Combined Review submissions to MHRA and ethics committees, ARSAC applications, RFIs, and amendments. Prepare, review, and quality-check key trial documents. Serve as primary contact for sponsors, MHRA, RECs, and ARSAC, negotiating practical solutions to regulatory comments. Lead regulatory discussions in sponsor and internal meetings. Advise colleagues on regulatory matters and manage urgent safety measures. Contribute to continuous quality improvement initiatives and CAPA processes. Provide training and mentorship to regulatory team members. Participate in audits and inspections by regulatory authorities. Support business development activities related to regulatory services. Maintain regulatory documentation and databases. Author and review regulatory SOPs and manage ARSAC licences. Qualifications & Experience Several years of relevant regulatory experience in a pharmaceutical company or CRO. Thorough knowledge of laws and guidance applicable to Phase 1 clinical trials. Proven ability to lead regulatory applications and submissions. Strong project leadership and teamwork skills. Excellent written and verbal communication skills. Ability to develop innovative solutions to regulatory challenges. High attention to detail and ability to manage multiple projects under tight deadlines. Job Demands High concentration and strict deadlines. Ability to juggle multiple tasks and work outside normal hours when required. Strong customer focus and responsiveness to sponsor requirements. Join Quotient Sciences and play a pivotal role in advancing clinical research through regulatory excellence. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Posted Thursday 4 September 2025 at 05:00 Quotient Sciences: Molecule to Cure. Fast. We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform,Translational Pharmaceutics, shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role Are you passionate about formulation science and ready to make a real impact in clinical development? We're looking for aSenior Formulation Scientist Ito support the delivery of cutting-edge aseptic and non-sterile pharmaceutical projects at our in Alnwick. This is a fantastic opportunity to work in a fast-paced, GMP-regulated environment where your expertise will help bring life-changing therapies to patients. What You'll Be Doing Supporting the development of innovative formulations for aseptic and non-sterile products. Ensuring all work complies with cGMP and cEHS standards. Collaborating on the resolution of quality events and deviations. Driving continuous improvement across formulation processes. Contributing to the technical transfer of products into clinical trial manufacturing. Participating in internal, client, and regulatory audits. Engaging in customer meetings and providing expert technical input. Managing project timelines to ensure successful and timely delivery. What You'll Bring A BSc (Hons) or equivalent in a relevant scientific discipline. Extensive experience in pharmaceutical aseptic and/or non-sterile manufacturing. Good awareness of the current GMP regulatory environment. Solid knowledge of sterile formulation development. Who You Are A clear and confident communicator, both written and verbal. Flexible, adaptable, and comfortable working in a dynamic setting. Detail-oriented with a strong commitment to quality. Willing to go the extra mile, including occasional work outside standard hours. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Jan 01, 2026
Full time
Posted Thursday 4 September 2025 at 05:00 Quotient Sciences: Molecule to Cure. Fast. We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform,Translational Pharmaceutics, shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role Are you passionate about formulation science and ready to make a real impact in clinical development? We're looking for aSenior Formulation Scientist Ito support the delivery of cutting-edge aseptic and non-sterile pharmaceutical projects at our in Alnwick. This is a fantastic opportunity to work in a fast-paced, GMP-regulated environment where your expertise will help bring life-changing therapies to patients. What You'll Be Doing Supporting the development of innovative formulations for aseptic and non-sterile products. Ensuring all work complies with cGMP and cEHS standards. Collaborating on the resolution of quality events and deviations. Driving continuous improvement across formulation processes. Contributing to the technical transfer of products into clinical trial manufacturing. Participating in internal, client, and regulatory audits. Engaging in customer meetings and providing expert technical input. Managing project timelines to ensure successful and timely delivery. What You'll Bring A BSc (Hons) or equivalent in a relevant scientific discipline. Extensive experience in pharmaceutical aseptic and/or non-sterile manufacturing. Good awareness of the current GMP regulatory environment. Solid knowledge of sterile formulation development. Who You Are A clear and confident communicator, both written and verbal. Flexible, adaptable, and comfortable working in a dynamic setting. Detail-oriented with a strong commitment to quality. Willing to go the extra mile, including occasional work outside standard hours. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Posted Thursday 4 September 2025 at 05:00 Quotient Sciences: Molecule to Cure. Fast. We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform,Translational Pharmaceutics, shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role Are you passionate about formulation science and ready to make a real impact in clinical development? We're looking for aSenior Formulation Scientist Ito support the delivery of cutting-edge aseptic and non-sterile pharmaceutical projects at our in Alnwick. This is a fantastic opportunity to work in a fast-paced, GMP-regulated environment where your expertise will help bring life-changing therapies to patients. What You'll Be Doing Supporting the development of innovative formulations for aseptic and non-sterile products. Ensuring all work complies with cGMP and cEHS standards. Collaborating on the resolution of quality events and deviations. Driving continuous improvement across formulation processes. Contributing to the technical transfer of products into clinical trial manufacturing. Participating in internal, client, and regulatory audits. Engaging in customer meetings and providing expert technical input. Managing project timelines to ensure successful and timely delivery. What You'll Bring A BSc (Hons) or equivalent in a relevant scientific discipline. Extensive experience in pharmaceutical aseptic and/or non-sterile manufacturing. Good awareness of the current GMP regulatory environment. Solid knowledge of sterile formulation development. Who You Are A clear and confident communicator, both written and verbal. Flexible, adaptable, and comfortable working in a dynamic setting. Detail-oriented with a strong commitment to quality. Willing to go the extra mile, including occasional work outside standard hours. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Jan 01, 2026
Full time
Posted Thursday 4 September 2025 at 05:00 Quotient Sciences: Molecule to Cure. Fast. We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform,Translational Pharmaceutics, shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role Are you passionate about formulation science and ready to make a real impact in clinical development? We're looking for aSenior Formulation Scientist Ito support the delivery of cutting-edge aseptic and non-sterile pharmaceutical projects at our in Alnwick. This is a fantastic opportunity to work in a fast-paced, GMP-regulated environment where your expertise will help bring life-changing therapies to patients. What You'll Be Doing Supporting the development of innovative formulations for aseptic and non-sterile products. Ensuring all work complies with cGMP and cEHS standards. Collaborating on the resolution of quality events and deviations. Driving continuous improvement across formulation processes. Contributing to the technical transfer of products into clinical trial manufacturing. Participating in internal, client, and regulatory audits. Engaging in customer meetings and providing expert technical input. Managing project timelines to ensure successful and timely delivery. What You'll Bring A BSc (Hons) or equivalent in a relevant scientific discipline. Extensive experience in pharmaceutical aseptic and/or non-sterile manufacturing. Good awareness of the current GMP regulatory environment. Solid knowledge of sterile formulation development. Who You Are A clear and confident communicator, both written and verbal. Flexible, adaptable, and comfortable working in a dynamic setting. Detail-oriented with a strong commitment to quality. Willing to go the extra mile, including occasional work outside standard hours. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.