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Director / Europe / Perm / Retained Search
Currently we are supporting a high growth Biotech focused on advancing breakthrough therapies in oncology.
Position Summary:
We are seeking a highly experienced and strategic Regulatory CMC Director to support the development of our oncology pipeline. This individual will play a critical role in leading regulatory CMC strategy, overseeing global submissions, and ensuring compliance with regulatory requirements for investigational oncology assets.
Key Responsibilities:
1. Develop and execute global regulatory CMC strategies for oncology development programs from early-phase to commercialization.
2. Provide expert guidance on CMC regulatory requirements for investigational new drug (IND) applications, new drug applications (NDA), biologics license applications (BLA), and marketing authorization applications (MAA).
3. Lead the preparation, review, and submission of high-quality CMC documentation for regulatory filings, including IMPDs, CTAs, INDs, NDAs, BLAs, and post-approval variations.
4. Serve as the primary CMC regulatory contact with global health authorities (e.g., FDA, EMA, MHRA), facilitating interactions, responding to inquiries, and negotiating regulatory pathways.
5. Collaborate cross-functionally with R&D, Quality, Manufacturing, and Regulatory Affairs teams to align CMC strategies with overall program goals.
6. Identify potential CMC risks, propose mitigation strategies, and ensure adherence to evolving regulatory requirements.
7. Support due diligence activities for in-licensing opportunities by assessing CMC regulatory aspects of potential assets.
8. Stay abreast of global regulatory developments, emerging trends, and industry best practices in oncology drug development.
Qualifications & Experience:
1. Advanced degree (PhD, MSc, or equivalent) in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
2. Minimum of 10 years of experience in Regulatory CMC within the pharmaceutical/biotechnology industry, with a strong focus on oncology.
3. Proven track record of leading successful CMC regulatory submissions for oncology products, including INDs, NDAs, and BLAs.
4. In-depth knowledge of global CMC regulatory guidelines (ICH, FDA, EMA, etc.) and their application to small molecules, biologics, or cell and gene therapies.
5. Strong understanding of pharmaceutical manufacturing, analytical methods, process development, and quality control principles.
6. Experience in interactions with regulatory agencies, including responding to inquiries and participating in health authority meetings.
7. Excellent leadership, communication, and project management skills.
8. Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams.
Preferred Qualifications:
1. Experience in peptides or ADCs are a plus.
2. Prior experience working in both large pharmaceutical and biotechnology startup environments.
Why Join Us?
1. Opportunity to make a significant impact in advancing innovative oncology treatments.
2. Collaborative and high-performing work environment.
3. Competitive compensation and benefits package.
4. Career growth and professional development opportunities in a rapidly evolving regulatory landscape.
Seniority level
Director
Employment type
Full-time
Job function
Science
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