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:
* Develop and execute global regulatory CMC strategies for oncology development programs from early-phase to commercialization.
* 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).
* Lead the preparation, review, and submission of high-quality CMC documentation for regulatory filings, including IMPDs, CTAs, INDs, NDAs, BLAs, and post-approval variations.
* 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.
* Collaborate cross-functionally with R&D, Quality, Manufacturing, and Regulatory Affairs teams to align CMC strategies with overall program goals.
* Identify potential CMC risks, propose mitigation strategies, and ensure adherence to evolving regulatory requirements.
* Support due diligence activities for in-licensing opportunities by assessing CMC regulatory aspects of potential assets.
* Stay abreast of global regulatory developments, emerging trends, and industry best practices in oncology drug development.
Qualifications & Experience:
* Advanced degree (PhD, MSc, or equivalent) in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
* Minimum of 10 years of experience in Regulatory CMC within the pharmaceutical/biotechnology industry, with a strong focus on oncology.
* Proven track record of leading successful CMC regulatory submissions for oncology products, including INDs, NDAs, and BLAs.
* In-depth knowledge of global CMC regulatory guidelines (ICH, FDA, EMA, etc.) and their application to small molecules, biologics, or cell and gene therapies.
* Strong understanding of pharmaceutical manufacturing, analytical methods, process development, and quality control principles.
* Experience in interactions with regulatory agencies, including responding to inquiries and participating in health authority meetings.
* Excellent leadership, communication, and project management skills.
* Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams.
Preferred Qualifications:
* Experience in peptides or ADCs are a plus.
* Prior experience working in both large pharmaceutical and biotechnology startup environments.
Why Join Us?
* Opportunity to make a significant impact in advancing innovative oncology treatments.
* Collaborative and high-performing work environment.
* Competitive compensation and benefits package.
* Career growth and professional development opportunities in a rapidly evolving regulatory landscape.