Job Description
Are you a visionary regulatory strategist ready to accelerate the delivery of life-saving oncology therapeutics? Vertex BioPharma Solutions is seeking a Senior Regulatory Affairs Manager to lead our high-profile pipeline through critical FDA and global milestones.
In this high-impact role, you will spearhead the preparation, compilation, and review of major regulatory submissions (IND, NDA, BLA). You will serve as the primary strategic voice, collaborating with elite scientific minds and negotiating directly with regulatory bodies to transform breakthrough molecules into approved standards of care.
We offer a cutting-edge scientific environment, industry-leading compensation, and the opportunity to make an immediate, tangible impact on global patient health.
Responsibilities
- Formulate and execute comprehensive global regulatory strategies for oncology pipeline assets from Phase I through commercialization.
- Lead the writing, critical review, and timely submission of INDs, NDAs, BLAs, and CTAs in compliance with FDA and international guidelines.
- Act as the primary liaison and lead representative in meetings with the FDA, EMA, and other major health authorities.
- Provide strategic regulatory guidance to cross-functional drug development teams, including clinical development, CMC, and pharmacovigilance.
- Monitor, interpret, and communicate rapidly evolving regulatory trends and guidelines to adapt current clinical programs proactively.
- Manage post-marketing regulatory compliance, including annual reports, safety updates, and label expansions.
Qualifications
- Bachelor’s degree in a life sciences discipline; PharmD, PhD, or Master’s degree is highly preferred.
- Minimum of 6-8 years of progressive regulatory affairs experience within the pharmaceutical or biotechnology sector.
- Proven track record of managing successful oncology IND/NDA/BLA submissions to the FDA.
- Comprehensive expert-level knowledge of FDA, ICH, and GCP regulations and guidelines.
- Strong experience leading formal negotiations and scientific discussions with health regulatory agencies.
- Demonstrated leadership, critical-thinking, and project management skills in a fast-paced, matrixed environment.