Job Description
Are you a visionary regulatory professional looking to accelerate life-saving oncology therapies to market? AstraNexus Therapeutics, a leading-edge biopharmaceutical pioneer, is seeking a high-caliber Senior Regulatory Affairs Manager to lead our global regulatory strategy.
In this high-impact role, you will serve as the primary conduit between our innovative research pipelines and global regulatory bodies. You will drive the submission lifecycle for breakthrough oncology assets, working alongside world-class scientists and clinical researchers in the heart of Boston's premier biotech hub. This is an exceptional opportunity to shape the future of cancer treatment and significantly impact patient lives worldwide.
Responsibilities
- Formulate and execute global regulatory strategies for early to late-stage oncology drug candidates.
- Lead the preparation, authoring, and submission of high-quality IND, NDA, and BLA applications to the FDA and international health authorities.
- Serve as the primary point of contact and lead negotiator during direct interactions and formal meetings with the FDA and other regulatory agencies.
- Collaborate with cross-functional teams, including Clinical Development, Medical Writing, Quality Assurance, and Pharmacovigilance, to ensure strategic alignment.
- Monitor the evolving global regulatory landscape, interpreting new guidelines and advising senior leadership on clinical development impacts.
- Manage external regulatory consultants and contract research organizations (CROs) to guarantee compliance and timely submissions.
Qualifications
- Bachelor's degree in a Life Sciences discipline (Biology, Chemistry, Pharmacology); Master's, PharmD, or PhD highly preferred.
- Minimum of 6 to 8 years of regulatory affairs experience within the pharmaceutical or biotechnology sector.
- Proven track record of successful IND, NDA, or BLA submissions, specifically with oncology or rare disease indications.
- Deep understanding of FDA, ICH, and EMA guidelines, GCP/GLP compliance, and the drug development lifecycle.
- Excellent communication and negotiation skills with a demonstrated history of leading productive FDA interactions.
- Strong project management capability, enabling execution of complex, multi-site global submissions under tight timelines.