Join a top 5 regulatory affairs consultancy with a strong global presence, specializing in providing strategic and technical regulatory support to pharmaceutical and biotech companies. Our team is dedicated to CMC regulatory excellence, supporting innovative therapies, including radiopharmaceuticals and theranostics, through all phases of development and commercialization.
The Role
We are seeking a highly skilled CMC Regulatory Affairs Writer with Module 3 expertise and a strong background in radiopharmaceuticals and theranostics. In this role, you will:
- Author and review high-quality CMC regulatory documents for INDs, IMPDs, NDAs, BLAs, and MAAs.
- Provide strategic CMC writing support for radiopharmaceutical products, ensuring compliance with FDA, EMA, and ICH guidelines.
- Collaborate with cross-functional teams, including CMC experts, regulatory strategists, and quality professionals.
- Work closely with clients and regulatory agencies to address CMC-related queries and submissions.
- Support post-approval changes, variations, and lifecycle management activities.
- Maintain up-to-date knowledge of evolving radiopharma regulations and theranostics-specific CMC requirements.
Requirements
- 5+ years of experience in CMC regulatory writing, with a focus on Module 3.
- Strong expertise in radiopharmaceuticals and theranostics (experience with alpha and beta emitters, PET tracers, or companion diagnostics is a plus).
- Proven experience in writing IND, IMPD, NDA, MAA, and BLA CMC sections.
- Deep understanding of FDA, EMA, and ICH CMC guidelines.
- Ability to interpret and apply GMP, quality control, and stability requirements for radiopharma products.
- Exceptional writing, analytical, and project management skills.
- PhD, MSc, or BSc in a relevant scientific discipline (e.g., Pharmaceutical Sciences, Chemistry, or Regulatory Affairs).
Why Join Us?
- Work for a top-tier regulatory consultancy with a stellar reputation.
- Fully remote role with flexible working hours.
- Engage in cutting-edge theranostics projects shaping the future of personalized medicine.
- Competitive salary, performance bonuses, and career development opportunities.
- Be part of a highly experienced, collaborative team in a fast-growing sector.
