Manager, Regulatory Affairs

Initial Therapeutics, Inc.; Redwood City (CA); On-site; USD 130,000 - 179,000; Full time

Benefits offered by this job

Annual bonus

Equity incentives

ESPP

ROTH 401(k)

Health plans

Paid time off

Job summary

Adicet Bio, Inc. seeks a Manager, Regulatory Affairs to lead global CMC regulatory strategies for its cell therapy programs. You will manage submissions and coordinate with FDA and international agencies while collaborating with development, QA, and manufacturing teams.

The ideal candidate will have extensive experience with FDA/ex-US submissions, strong scientific background, and the ability to drive timelines in a fast-paced setting. Onsite presence is required for collaboration across teams.

Qualifications

• Experience with FDA and/or ex-US submissions.
• Understanding INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.
• BA/BS in life sciences, pharmacy, or related field; advanced degree preferred.
• At least eight years in Regulatory Affairs in biotech/pharma, with five years in Regulatory CMC.
• Experience in QA, analytical testing, manufacturing, and research.

Responsibilities

• Support regulatory CMC functions to drive global regulatory timelines and milestones throughout product development.
• Prepare and file regulatory CMC submissions, commitments, and change amendments; author/review regulatory documents for high quality submissions.
• Assist senior RA staff in meetings with FDA and ex-US regulatory agencies (e.g., pre-IND, End of Phase, Scientific Advice).
• Review CMC, clinical, and nonclinical docs for GxP and regulatory compliance.
• Maintain and track company databases for regulatory submissions, agency communications, commitments, and information requests.
• Interface with internal teams, external partners and consultants to drive projects to completion.
• Stay current with global regulations and communicate changes to cross-functional teams.
• Develop skills related to submission publishing of electronic CTD compliant documentation.

Skills

Regulatory strategy

CMC submissions

FDA/ex-US submissions

Regulatory documentation

Cross-functional collaboration

Education

BA/BS in life sciences or related field

Advanced degree preferred

Tools

MS Office

eCTD publishing tools

Job description

JOIN US!

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of off-the-shelf gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

Manager, Regulatory Affairs

Adicet 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.

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 autoimmune diseases and 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 13 company holidays, paid end-of-year winter break, 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, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.