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Adicet Bio, Inc · 1 day ago

Manager, Regulatory Affairs

Redwood City, CA

Full-time

Hybrid

Mid, Senior Level

$124K/yr - $171K/yr

5+ years exp

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager of Regulatory Affairs will be responsible for managing the global regulatory implementation of assigned projects and ensuring timely and robust regulatory strategies and submissions.

BiopharmaBiotechnologyHealth CareMedical

Responsibilities

Support the regulatory function in assigned projects to drive global regulatory

Provide regulatory strategy, guidance and input throughout product

Manage the preparation and filing of regulatory applications, commitments, and change amendments. Author and review regulatory documents to ensure that all submissions are of high

Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages

Review clinical and CMC documentation, including protocols, reports, DSUR’s, Investigator Brochures, change controls, certificates of analyses, etc. to ensure GxP and regulatory compliance

Create and maintain regulatory timelines and track deliverables to ensure submission timelines are met for assigned projects

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

Qualification

Regulatory AffairsBiotechnology experienceDrug regulations knowledgeQuality assuranceAnalytical testingTeam collaborationOrganizational skillsAttention to detailWritten communicationVerbal communication

Required

Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields

At least five years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry

Experience in quality assurance, analytical testing, and research

Knowledge and experience in interpretation of regulations and guidelines related to drug development

The desire and ability to work in a fast-paced, start-up environment

Strong collaboration, teamwork, organizational skills, and attention to detail

Excellent written and verbal communication skills

Preferred

Advanced degree is preferred

Benefits

Competitive compensation package including base salary, annual cash bonus, long-term incentives (equity)

Employee Stock Purchase Plan (ESPP)

401(k) with ROTH and a 4.5% Company match

Comprehensive health plans (medical, dental, vision, etc.)

Flexible Health and Commuter Spending Accounts (FSA)

Company matched Health Savings Account (HSA)

Life, AD&D, short and long-term disability insurance

Legal, pet, and various other voluntary insurance programs

Generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave

Onsite gym and various other fitness options

Onsite parking with electric vehicle charging stations and free shuttle (Caltrain)

Company-subsidized lunches (delivered onsite daily)

Fully stocked breakrooms

Company

Adicet Bio, Inc

At Adicet (Nasdaq: ACET), we are defined by our mission to deliver best-in-class gamma-delta T cell therapies for patients fighting autoimmune diseases and cancer.

Founded in 2014

Redwood City, California, USA

51-200 employees