Manager, Regulatory Affairs (Clinical and Nonclinical focus)

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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

MANAGER, REGULATORY AFFAIRS (Clinical and Nonclinical focus)

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 Adicet Bio 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 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.
   

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 organisational 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 centralised procedure.
• Experience in supporting post-approval management of variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
• Experience in working with document management systems.

Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

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 is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $126,000.00 - $174,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.