Senior Director Regulatory CMC

Retained Search

Our client is a clinical-stage biotechnology company leveraging its immune tolerance platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. The Senior Director will be accountable for driving the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (BLAs/MAAs).

Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends.
• Excellent knowledge of ICH requirements for the Quality aspect of the development of large molecules.
• Lead early development (Pre-IND) to registration and commercialization in the US and EU and other major markets.
• Develop documents for IND and BLA submissions in eCTD format.
• Writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA,v5  and equivalent.
• Writing and reviewing briefing packages for meetings with regulatory bodies (US FDA, EMA, and others)
• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies.
• Experience in successfully leading the CMC component of meetings with major regulatory bodies such as FDA and EMA.
• Interpret GMP-related matters and review of CMC aspect of regulatory documents.
• Manages and or mentors staff members.
• Ability to significantly contribute to both developmental and commercial (marketed product) teams.

Qualifications:

• A Masters’ degree in biology, biochemical engineering, biochemistry or analytical chemistry, or related subject (Ph.D. preferred).
• 10+ years of Regulatory CMC experience with large molecules (biotechnology products) with FDA or biotechnology industry or combination.
• Experience with large molecules (therapeutic proteins produced by recombinant DNA technology).
• Extensive experience in developing documents for IND and BLA submissions in eCTD format.
• Experience also with gene therapy products is a plus.
• Experience in writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA.
• Experience in the development and review of CMC regulatory documents for small molecules.
• The ability of independent thinking and decision making in collaboration with team members.
• Can do attitude and being excited about bringing new treatments to patients faster.
• Ability to interpret GMP related matters and review of CMC aspect of regulatory documents.
• Ability to independently plan, execute and manage regulatory submissions for assigned products in clinical development, during global registrations, and post-approval life cycle activities.
• Expertise in reviewing documents pertaining to due diligence for new business opportunities.
• Outstanding oral and written communication and negotiating skills.

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