Job Description

SENIOR MANAGER, REGULATORY AFFAIRS

The Senior Manager, Regulatory Affairs, with a clinical and non-clinical focus, prepares and submits regulatory filing documents and monitors and tracks information and requirement changes, with some interaction with regulatory agencies.

Key Responsibilities:

• Partner with research 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 Adicet Bio and establish productive relationships with appropriate FDA personnel and ex-US Regulatory Authorities to ensure the organization has a 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.
• Coordinate, assemble and/or prepare for submission various materials to the FDA and ex-US Regulatory Authorities, RMAT submissions 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.
• Partner with CRO organizations to ensure timely, submission of applications for Clinical Trials in markets where Adicet Bio does 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.
• Attention to detail with accuracy and understanding of the FDA guidelines within a regulatory environment.
• Excellent project management and organizational skills with the ability to multi-task deadlines/timelines within a fast-paced environment.
• Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
• Knowledge of Statutory Framework and Guidance procedures followed by FDA/EMA.

Education:

• 4yrs. bachelor\'s degree within a scientific discipline or advanced degree preferred.
• 5yrs+ experience within regulatory affairs environment within biotechnology/pharmaceutical industry.
• Strong understanding of gene/cell therapies within an early development phase.
• Demonstrate relevant regulatory affairs experience and understanding the global regulatory requirements within EU.
• Experience in supporting post-approval management of variations, renewals, responses to questions, PSURs etc. for EU centralized products is desirable.
• Experience in within document management systems and processes, such as Veeva Vault, Master Control, etc.

Benefits

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet Bio