Job Description
Regulatory Affairs Director - Customer Dedicated - Oncology
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
If you re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD clinical research services is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster.
We are currently seeking a Regulatory Affairs Director. This is an oversight role within our Regulatory FSP Solutions team. This position is supporting projects for one of our strategic partners on behalf of PPD Clinical Trial Services. This is a full-time, permanent position, and we can offer remote opportunities as well.
The purpose of this role is to ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal Client process / policy and with regional regulatory requirements to deliver the best possible labelling, commensurate with the available data.
In performing the role, the job holder will be responsible for:
• Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally
• Implementation of the regional strategy(s) in support of the project globally
• Lead regulatory interactions and the review processes in local region
• Ensuring appropriate interaction with regional commercial teams in local region
• Ensuring compliance with regional requirements at all stages of product life
• Ideally able to advocate persuasively approaches to senior leaders in the Business and in Health Authorities
• Capable of providing assessment of potential in license molecules
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
15+ years).
Extensive experience of all phases of the drug development process in regulatory affairs
Proven experience of leading regional development, submission and approval activities regionally/globally.
Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
Knowledge of Oncology
Knowledge, Skills and Abilities:
- Mastery of English language (written and oral) communication skills as well as local language where applicable
- Sharp attention to detail and quality as well as advanced editorial/proofreading skills
- Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Professional negotiation skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Advanced understanding of medical terminology, statistical concepts, and guidelines
- Sharp analytical, investigative and problem-solving skills
- Advanced understanding of budgeting and forecasting
- Recognized executive presence and consultation and presentation skills
- Effective critical and strategic thinking skills
At PPD clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world s most urgent health needs, submit your application - we d love to hear from you!
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