Job Description
About Aegis Biopharma
Aegis Biopharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing life-altering therapies for oncology and rare immunological conditions. We operate at the intersection of cutting-edge molecular biology and high-throughput drug design, striving to transform scientific breakthroughs into robust therapeutics that improve patient outcomes globally.
The Role
We are seeking a high-caliber Senior Regulatory Affairs Manager to lead our global regulatory strategy. In this role, you will act as the primary liaison with global regulatory bodies (such as the FDA, EMA, and PMDA) and oversee the preparation, submission, and lifecycle maintenance of our Investigational New Drug (IND) and New Drug Applications (NDA). This is a high-visibility, strategic role designed for an ambitious regulatory professional looking to drive breakthrough therapies to market.
Responsibilities
- Formulate and execute comprehensive global regulatory strategies for early to late-stage drug candidates.
- Lead the compilation, authoring, and clinical review of major submissions, including INDs, NDAs, CTAs, and BLAs.
- Act as the primary point of contact and lead negotiator with health authorities during scheduled key meetings.
- Collaborate with cross-functional teams, including Clinical Development, Toxicology, and CMC, to align clinical trial protocols with international regulatory standards.
- Monitor, interpret, and educate internal stakeholders on evolving global regulatory guidelines and policies.
- Manage external regulatory consultants and CROs to ensure submissions are delivered accurately and ahead of critical clinical timelines.
Qualifications
- Bachelor's degree in Pharmacy, Pharmacology, Chemistry, Biology, or a related life-sciences discipline (advanced degree such as PhD, PharmD, or MS is highly preferred).
- Minimum of 6-8 years of hands-on regulatory affairs experience within the pharmaceutical or biotechnology sector.
- Proven track record of driving successful clinical-stage submissions (specifically IND, CTA, or NDA) to major global agencies.
- Deep working knowledge of FDA regulations, ICH guidelines, and accelerated clinical development pathways.
- Exceptional technical writing skills with the ability to translate complex clinical data into compelling regulatory documents.
- Strong interpersonal and communication leadership skills to guide matrixed development teams.