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Regulatory Affairs Manager

  • Location: Redwood City
  • $ Salary: US$126000.00 - US$174000.00 per annum per year
  • Job Type:Permanent

Posted 25 days ago


The Manager, Regulatory Affairs prepares and submits regulatory filing documents and monitors and tracks information and requirement changes, with some interaction with regulatory agencies.

Key responsibilities:

  • 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.

Core competencies:

  • 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.