Manager, Regulatory AffairsAdicet Bio is seeking a highly motivated Manager, Regulatory Affairs, who is passionate in the field of cell therapy development for oncology and autoimmune patients. They are curious learner, dedicated, highly focused, and welcome unexpected challenges. The desired candidate must enjoy a fast-paced, dynamic, and interactive work environment.
The Manager will report into the Regulatory group devoted to developing regulatory strategies that support rapid clinical and product development of cell therapies. They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions.
Key responsibilities:- Support the regulatory CMC functions in assigned project(s) to drive global regulatory timelines and milestones throughout the lifecycle of product development.
- Manage the preparation and filing of regulatory CMC submissions, commitments, and change amendments. Author and review regulatory CMC documents to ensure that all submissions are of high
- Assist senior RA staff in the development of Meeting Requests, Briefing Books and meeting materials for FDA and ex-US regulatory agency meetings, including pre-IND meetings, End of Phase meetings, Scientific Advice, etc.
- Review CMC, clinical, and nonclinical documentation, including change controls, certificates of analyses, labels, study reports, clinical protocols, DSURs, Investigator Brochures, to ensure GxP and regulatory compliance.
- Assist in maintenance and tracking of company databases, including regulatory submissions, agency communications, commitments, agency information requests and responses, etc.
- Interface with functional areas, external partners and consultants, as
- Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development and communicate changes in regulatory information to cross-functional
teams.
- Opportunity to develop publishing skills related to submission of electronic CTD compliant documentation.
Qualifications:- Experienced in FDA and/or ex-US submissions.
- Understand the general requirements of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.
- Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields. Advanced degree is preferred.
- At least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry, with five years of Regulatory CMC experience.
- Previous experience in quality assurance, analytical testing, manufacturing, and research is
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 multiple 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.
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite
at least three days per week (Tuesday-Thursday mandatory), with some roles requiring full-time onsite presence.
Pay Range
$130,000-$179,000 USD
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite
at least three days per week (Tuesday-Thursday mandatory), with some roles requiring full-time onsite presence.
