Project Manager Global Regulatory Affairs

We're seeking an experienced Regulatory Affairs Global Project Manager to lead our regulatory strategy and submissions across multiple global markets. This is a high-impact role where you'll bridge global regulatory teams, manufacturing operations, and cross-functional stakeholders to drive successful product approvals for life-changing therapies.

What You'll Do

- Lead global regulatory strategies for cell & gene therapies, biosimilars, and biologics across FDA, EMA, PMDA, and other jurisdictions
- Manage complex regulatory projects from IND/CTA to BLA/MAA submissions and post-approval lifecycle management
- Drive cross-functional collaboration with R&D, Quality, Manufacturing, and Clinical teams globally
- Ensure CMC compliance for advanced therapy manufacturing processes and tech transfers
- Navigate health authority interactions including pre-submission meetings, information requests, and inspections
- Mentor and develop regulatory team members while driving continuous improvement

What We're Looking For

Essential:

- 8-10+ years in regulatory affairs within biopharma
- 5+ years with cell & gene therapies, biosimilars, biologics, or large molecules
- Proven track record of successful FDA, EMA, and global regulatory approvals
- Deep expertise in CMC requirements and eCTD submissions
- Strong knowledge of ICH guidelines, ATMP regulations, and GMP for biologics
- Bachelor's in Life Sciences/Pharmacy/Biotechnology (Master's/PhD preferred)

Bonus Points:

- RAC-US or RAC-EU certification

- Experience with CDSCO (Indian regulatory authority)
- Background in cell therapy manufacturing or gene therapy vector production
- Expedited pathway experience (Fast Track, Breakthrough Therapy, PRIME)

What We Offer

- Professional development opportunities and continuing education support
- Hybrid work options with flexibility
- Strategic location in Vapi's thriving pharma & biotech hub with world-class infrastructure
- Impactful work on therapies that change lives