Location: Newton, MA
The Regulatory Affairs Manager will be responsible for preparing and maintaining regulatory submission in line with FDA and ICH requirements.
- Responsible for the preparation of regulatory submissions in compliance with global requirements. These may include US IND and related amendments, ex-US CTAs and related amendments, and global safety and annual reports.
- Support meetings with Regulatory Authorities including requesting agency meetings and publishing of associated briefing documents.
- Work closely with Regulatory Operations to ensure submissions are well planned and meet current standards and submission schedules are adhered to.
- Manage team reviews of regulatory submissions, authored in-house and/or prepared by CRO’s or consultants.
- Represent regulatory on relevant project teams.
- Participate in sub teams depending on the complexity of the project.
- Maintain up-to-date knowledge of regulatory requirements and communicate in a timely manner any updates that may impact the development programs.
Skills & Requirements:
- BA/BS degree in life sciences, regulatory affairs, or other relevant discipline.
- 5 years of experience in regulatory affairs with multiple types of US regulatory submissions. Ex-US experience and oncology experience a plus.
- Knowledge and experience with drafting regulatory documents including forms, cover letters and reports, creation of electronic documentation (bookmarking and hyperlinking) and electronic archiving.
- Proficient with MS Word, Excel, Power Point and Adobe Professional. Exposure to electronic document management software is desirable.
- Ability to work effectively with cross-functional departments, RA colleagues, Regulatory Operations, and teams.
- Strong verbal and written communication skills.