Our client is a late-stage biopharmaceutical company engaged in the development and commercialization of human therapeutics. They have asked us to assist them in their search for a Director, Global CMC Regulatory Affairs.
The Director, Global CMC Regulatory Affairs is responsible for leading all regulatory CMC development, registration, and compliance activities from early development through commercialization.
Major tasks and responsibilities will include: Works closely with colleagues and cross-functional project teams to develop CMC regulatory submission strategies, review content, and maintain submission timelines to successfully meet business objectives. Assesses and communicates CMC regulatory requirements. Ensures all development activities are in compliance with applicable regulations and guidelines. Works with CMC colleagues to develop Quality by Design (QbD) strategies for novel manufacturing processes. Assists in the conduct and appropriate documentation of all QbD related activities. Conducts risk assessments and develops mitigation strategies for global CMC regulatory matters. Leads efforts for developing all CMC content of original INDs, IND amendments, investigational medicinal product dossiers (IMPD), and NDAs. Interfaces with regulatory agencies on all CMC matters. Leads preparations for regulatory agency CMC meetings. Effectively communicates novel manufacturing processes and QbD activities to regulatory agencies. Works closely with Manufacturing and Quality colleagues to prepare for GMP facility inspections by health authorities. Ensures all corrective actions are completed, documented, and properly communicated. Ensures that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements. Establishes, manages, and maintains a knowledge base of current and emerging global CMC regulatory requirements and guidelines. Ensures overall operation is within the approved budget and timeline.
We seek candidates with the following qualifications: Bachelors degree in chemistry, biochemistry, engineering, life sciences or related field required. Advanced degree highly preferred. A minimum of 10 years of CMC regulatory experience in the pharmaceutical industry. Must have strong knowledge of drug development, with some small molecule experience. Requires understanding of and experience with pharmaceutical QbD concepts and techniques. Must have excellent knowledge of FDA and ICH requirements and guidelines, with experience as FDA liaison. Knowledge of EU regulations and guidelines highly preferred. Requires experience in authoring and filing INDs, IMPDs, and NDAs. Experience in post-market and commercialization regulatory CMC activities required. RAC certification highly preferred. Must have proven evaluative, analytical, and interpretative skills enabling review and synthesis of information used in regulatory planning and submissions. Demonstrated project management skills required. Must be capable of multi-tasking, setting priorities, and meeting timelines in a fast-paced, innovative environment with minimal supervision. Supervisory oversight of contract service providers, external consultants, and in-house project teams required. Must be able and willing to travel up to 10%.
If interested, please email your resume as a Word attachment to us, reference 3809. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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