Job Description
At Genovex Therapeutics, we are redefining the landscape of modern medicine. We are seeking a visionary Senior Regulatory Affairs Specialist to join our elite Regulatory Affairs team in San Francisco. In this pivotal role, you will be instrumental in steering our pipeline of innovative oncology therapeutics through the complex regulatory landscape of the FDA and EMA.
As a key driver of our commercialization strategy, you will leverage your deep expertise to ensure compliance, accelerate time-to-market, and secure the future of patient access to life-saving treatments. If you are a strategic thinker ready to make a tangible impact on global health, we want to hear from you.
Why Join Genovex?
- Work with cutting-edge biologics and small-molecule drugs.
- Competitive compensation and comprehensive benefits package.
- Collaborative, innovation-driven culture in the heart of Biotech Bay.
Responsibilities
- Lead the preparation, review, and submission of regulatory filings including NDAs, ANDAs, and BLAs to the FDA and EMA.
- Orchestrate the Master File strategy and manage complex Chemistry, Manufacturing, and Controls (CMC) documentation.
- Act as the primary liaison between cross-functional teams (R&D, Quality, Clinical) and regulatory authorities.
- Manage regulatory project timelines, ensuring milestones are met within critical path constraints.
- Conduct gap analyses to ensure ongoing compliance with 21 CFR, GMP, and GLP regulations.
- Prepare and present regulatory strategies and regulatory intelligence to executive leadership.
Qualifications
- Master’s or Bachelor’s degree in Pharmacy, Biology, Chemistry, or related scientific field; RAC certification preferred.
- Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA 21 CFR Part 11, GMP, and GLP regulations.
- Proven track record of successful IND, NDA, or MAA submissions.
- Exceptional written and verbal communication skills with the ability to influence key stakeholders.
- Strong project management skills with meticulous attention to detail.