Associate Director, Regulatory CMC
1 month ago
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
Responsibilities:
- Provide expert CMC guidance and technical expertise for multiple projects with a focus on small molecules.
- Contribute to development of regulatory CMC strategies as part of a cross functional team.
- As required, author global quality regulatory documentation including IMPDs, INDs, briefing books.
- Stay up-to-date on relevant regulatory developments in Europe through attending internal training sessions and workshops.
- Contribute to the ongoing improvement of internal regulatory processes and procedures.
- Mentor and coach junior staff, line management if necessary
- Support identification of business opportunities and development of client budgets and business proposals
- Build strong client relationships, manage client expectations and lead client strategy discussions
Requirements:
- Advanced degree (MSc/PhD) in a relevant field preferred.
- Bachelor's degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.
- Minimum 8+ years working in the pharmaceutical industry with substantial experience in small molecules with additional large molecule experience desirable.
- Knowledge of CMC requirements during clinical development and experience with global CMC regulations.
- Experience with developing gap analyses and effective regulatory strategies for small molecules.
- Experience in writing Module 3/2.3 of the CTD and contributing to briefing books
- Proven track record of leading and delivering successful projects within budget and timeframe and managing client relationships
- Strong business development and client management skills
- Organised, proactive and self-motivated individual with a keen eye for detail, ability to prioritise tasks effectively and ability to delegate to team members
- Must have experience working in a client-facing role and be able to represent ProPharma Group at its best
If you're an experienced regulatory professional who is passionate about delivering exceptional service to clients and enjoys working in a fast-paced, dynamic environment, we want to hear from you. ProPharma offers a competitive salary, excellent benefits package, and opportunities for professional development and advancement. Apply today to join our team
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