Senior Regulatory Affairs Specialist

SENIOR REGULATORY AFFAIRS SPECIALIST

OVERVIEW:

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology and infectious disease therapeutic areas.

RESPONSIBILITIES:

· Ensures maintenance of assigned, authorised products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
· For assigned products ensures timely, accurate and compliant labelling and artwork preparation.
· For assigned products and tasks, stays updated on late pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
· For assigned products and tasks, works alongside Business Development, locally, regionally, and globally, to support business initiatives in sub region.
· Maintains a positive relationship with internal and external regulatory contacts. GRACS on sub-regional, regional, and global level, MMD, EUQPPV and GCS&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
· By discretion of Regulatory Affairs Management and due to organisation and workload, all listed activities need not to be performed.
· Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
· For major indications, designs and implements local action plans as above mentioned for new MA applications.
· Works with Regulatory Affairs Europe to develop and implement regulatory strategies (including scientific advice and paediatric investigational plans, or orphan designation), identifies regulatory risks, and enables earliest possible approval. Ensures regulatory strategies are aligned with local business objectives and deliverables.
· For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, Prescribing Information, packaging material and other applicable regulatory documents according to local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
· Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
· Ensures the correct and proper utilisation of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
· Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
· Ensures that files and archives related to Regulatory are kept updated and complete.
· Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
· Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
· Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Information Leaflets.
· Ensures availability of packaging material, including patient information leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
· Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
· Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
· Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
· Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
· Participates, provides active input and lead if the case the local Medical Governance.

QUALIFICATIONS & SKILLS:

· BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.
· Comprehension of the fast evolving EU/UK regulatory procedures especially in light of BREXIT, and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority.
· Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
· Ability to identify compliance risks and escalate when necessary
· Sound knowledge of labelling requirements.
· Experience in managing regulatory projects
· Meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
· A mature and disciplined approach to work is essential as is the ability to coordinate the work of others.
· Demonstrate diplomacy and assertive skills in dealing with internal and external parties.