MANAGER, REGULATORY AFFAIRS
The Manager, Regulatory Affairs prepares and submits regulatory filing documents and monitors and tracks information and requirement changes, with some interaction with regulatory agencies.
- Assist Senior RA staff in the development of Regulatory Submissions for IND's/DMFs/ARs/DSUR's/OD/RMAT/BTD etc. and amendments/supplements.
- Coordinate, assemble and/or prepare for submission various materials to the FDA and ex-US Regulatory Authorities, such as IND's/DMFs/ARs/DSUR's/OD/RMAT/BTD etc. and amendments/supplements.
- Represent our organization and establish productive relationships with appropriate FDA personnel and ex-US Regulatory Authorities and to assure that the Company has an understanding of all applicable laws, regulations, and guidance.
- Assist in maintenance of the various company inhouse data bases, such as list of approved applications and tracking systems for regulatory submissions.
- Assist Senior RA staff in the development of Briefing Books for Agency meetings including pre-IND meetings, End of Phase meetings, RMAT submissions etc.
- Coordinate, assemble and/or prepare for submission various materials to the FDA and ex-US Regulatory Authorities, including Briefing Books for pre-IND submissions, End of Phase meeting etc.
- Work with Program Teams and Regulatory Department to define optimal RA strategy to take products through the development process to registration and commercialization.
- Support the preparation of regulatory submissions for investigational products through the development process to registration and commercialization, for ATMP's.
- Support the development of regulatory strategies in the US and ex-US countries.
- Interact with cross-function teams to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
- Work with CRO partner organizations to ensure timely, submission of applications for Clinical Trials in markets where we do not currently have a presence.
- Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.
- Opportunity to develop publishing skills related to submission of electronic CTD compliant documentation.
Key role-related competencies:
- Able to facilitate/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 scientific background and understanding with the ability to acquire this knowledge in a short timeframe.
- Knowledge of Statutory Framework and Guidance procedures followed by FDA/EMA.
- Understanding of product development.
- Strong verbal and written communication skills.
- Must have strong working knowledge of Microsoft Office and other PC-related applications.
- Must take initiative and have ability to work independently and as a team member, offer assistance wherever needed.
- Excellent oral and written English communication skills.
- Excellent planning and organizational skills with the ability to work simultaneously on a number of projects with tight timelines.
- Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
- Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
- 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.
Education and / or Experience required:
- Bachelor's Degree in scientific discipline required, advanced degree preferred.
- Life Science degree and demonstrated relevant regulatory affairs experience.
- An understanding of regulatory requirements for the EU centralized procedure.
- Experience in supporting post-approval management of variations, renewals, responses to questions, PSURs etc. for EU centralized products is desirable.
- Experience in working with document management systems.