Senior Regulatory Affairs Associate - Liver Diseases
Cambridge, United Kingdom
- A career within Gilead’s fast paced regulatory team will give you the opportunity to grow your experience quickly. Working with an experienced team of regulatory leaders each role within the Regulatory team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients quickly;
- An exciting opportunity has arisen for a Senior Associate, Regulatory Affairs, Liver Diseases to join the International Regulatory Affairs team based in Cambridge. The person in this role will provide regulatory support to Gilead’s Liver Disease product portfolio and will be responsible for the preparation of regulatory submissions for investigational and commercial hepatitis (B or C) and/or liver fibrosis medicinal products.
Essential Duties and Job Functions
- Prepares and/or co-ordinates the submission of non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the Marketing Authorisation Holder, e.g. renewals, variations, responses to questions, Follow-up Measures, PSURs etc.;
- Prepares and maintains labelling to support MAAs and for ensuring product packaging and associated information is updated and maintained in accordance with Marketing Authorisations in International RA-responsible territories, including the review and provision of accurate labeling translations;
- Supports the development and maintenance of the core Rest of World dossier and facilitating scientific responses to questions to Agency questions;
- Prepares and/or co-ordinates the regulatory documentation to support Clinical Trial Applications/amendments, scientific advice procedures and Paediatric Investigational Plans (PIP) for development compounds where required;
- Represents the International Regulatory Affairs function at cross-functional submission team meetings and cross-regional regulatory project team meetings, and presents project status updates and strategic approaches for supported projects;
- Provides advice and practical input in the preparation of country specific labeling across the development and marketed liver diseases product portfolio and may be required to support preparation of labeling for Marketing Authorisation Applications for liver disease products in development;
- Maintains a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams and senior management;
- Participates in routine local process improvements, which have an impact on the working of the Regulatory Affairs function;
- Supports the Liver Disease team as required.
Knowledge, Experience and Skills
- Degree in biological/life sciences, pharmacy or medicine (or international equivalent) with an advanced degree desirable (but not essential);
- Experience of either post-licensing or clinical trials work, as detailed below, is mandatory with experience in the remaining discipline highly desirable:
- Experience in the preparation/submission of regulatory documentation to support variations renewals, variations, responses to questions, Follow-up Measures, PSURs etc for Centralized products. Centralized MAA experience;
- Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials.
- Experience representing Regulatory Affairs on cross functional teams is mandatory.
- Excellent oral and written English communications skills and ability to work both within the group and across cross functional groups;
- Demonstrated effectiveness in cooperation and teamwork with judgment/problem solving and analytical and assessment skills;
- Planning and information seeking skills and ability to work independently;
- Problem solving, with ability to impact and influence;
- Attention to detail with accuracy and quality;
- Ability to understand and effectively relate to external and internal customers;
- Business awareness and professionalism.
Key Role-related Competencies
- Able to facilitate and take part in planning interactions and discussions;
- Able to effectively interact with external parties to information gather and effectively manage projects through to completion to tight timelines;
- A good knowledge of the antiviral and/or fibrosis therapeutic area or a good scientific background and understanding, with the ability to acquire scientific knowledge in a short timeframe.
Must be able to facilitate effective interactions within International Regulatory, as well as with other departments and sites within the company (Clinical Research, Medical Affairs, Safety, Legal, Commercial Operations), and Gilead affiliates, distributors and partners.
Limited European and US travel may be required.