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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 2 months 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.