Regulatory Affairs Jobs - Cambridge. A Regulatory Project Manager is wanted to join one of the world's foremost Biopharmaceutical companies. This company has a fantastic reputation for developing ground breaking therapeutics to treat life threatening diseases.
Under supervision of the director this individual will be responsible for the submission and maintenance of EU and RoW clinical trial applications for a key therapy area for which there will be extensive activity over the next year or so. It is essential you have clinical trials experience and are able to hit the ground running.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
This position will report to the Director or Senior Manager in International Regulatory Affairs and will be responsible for the preparation of regulatory submissions for investigational and commercial medicinal products.
For investigational medicinal products in the therapeutic area prepares and/or co-ordinates the preparation of regulatory documentation to support Clinical Trial Applications/ amendments, scientific advice procedures and Paediatric Investigational Plans (PIP) in the European Union.
Where required for licenced products, 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 via the European Centralised procedure, e.g. renewals, variations, responses to questions, Follow-up Measures , PSURs etc.
Where required is responsible for ensuring product packaging and associated information is updated and maintained in accordance with Marketing Authorisations in Cambridge-responsible territories including the review and provision of accurate labeling translations.
Represents International Regulatory function at cross functional submission team meetings.
Interacts with the Global Regulatory teams to ensure optimal execution of the agreed regulatory strategy for licenced and development medicinal products.
Provide advice and practical input on labeling issues across the development and marketed product portfolio
Responsible for maintaining a working knowledge of regulatory requirements and guidelines.
Supports the Director/Senior Manager as required.
COMPANY CORE VALUES
Teamwork, Excellence, Accountability, Integrity
CORE COMPETENCIES
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, strategic thinking skills 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 impact and influence effective planning interactions and discussions
Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines.
A good knowledge of the antiviral therapeutic area or a good scientific background and understanding with the ability to acquire this knowledge in a short timeframe.
EDUCATION and/or EXPERIENCE REQUIRED
Degree in biological/life sciences pharmacy or medicine. An advanced degree is desirable.
Experience representing Regulatory Affairs on cross functional teams is mandatory.
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 in post-licensing managements of variations renewals, variations, responses to questions, Follow-up Measures, PSURs etc for Centralized products.
This job was posted 30+ days ago, and has expired.
