Senior Manager, Regulatory Affairs CMC
Regulatory Affairs | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Senior Manager, CMC Regulatory Affairs to join the team.
Responsibilities include, but are not limited to:
- Lead and/or support preparation (planning, authoring, reviewing) of CMC-related regulatory submissions (e.g., INDs, CTAs, amendments, DSURs, meeting briefing packages) for one or more products in early-to-late development to meet company goals.
- Work closely with multiple functions to create high quality regulatory submissions that support product development strategy and ensure CMC content that meets current regional requirements
- Research and interpret global CMC regulations and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization
- Participate and contribute regulatory CMC guidance in assigned cross-functional project teams
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes
- Additional duties as assigned
Position Requirements & Experience:
- BA/MS degree in life sciences or related disciple is required. Ph.D. is desirable
- Approximately 5- 8 years of relevant biopharmaceutical industry experience, with minimum 5 years in CMC Regulatory Affairs. Less experience acceptable for suitable candidates with equivalent relevant industry experience.
- Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements.
- Understanding of global regulatory requirements for biologics and/or cell therapy. Experience in oncology/rare disease drug development a plus
- Understanding of drug development and life cycle management concepts and interdependencies with the overall development process
- Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence
- Effective planning, organizational and interpersonal skills. Ability to prioritize effectively to deliver results within reasonably established timelines
- Good technical writing skill
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.