Description: Our client is currently seeking a Director, CMC Regulatory Affairs
Key Responsibilities:
Regulatory Strategy & Submissions
Develop and implement global regulatory strategies for CMC aspects of drug development, including clinical trials, marketing applications, and post-approval changes.
Lead CMC submissions (IND, NDA, BLA, MAA, etc.) in collaboration with Regulatory Affairs and project teams, ensuring compliance with FDA, EMA, and other regulatory authorities, and to lead any agency CMC interactions.
Guide the creation and market entry of pharmaceutical products, maintaining a balance between innovation and regulatory compliance, including maintaining and extending product registrations in US, Europe and ROW.
Support the regulatory submission forms to support regulatory release and QP certification.
Provide expertise in authoring, reviewing, and approving CMC sections for regulatory submissions, amendments, supplements, and variations.
Provide guidance with regards to post-approval Regulatory CMC Strategy including commercialization, product launch and post-marketing commitments.
Provide expertise in regulatory CMC strategy for a drug device combination package including responsibility for module 3.2.R., 21 CFR part 820.30 or ISO 13485
Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
Collaboration & Communication
Serve as a primary CMC regulatory contact with health authorities and provide responses to queries.
Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes
As the global CMC/quality regulatory expert, ensure any necessary knowledge is transferred throughout the Regulatory team and internal stakeholders.
Work closely with internal departments such as Quality, Clinical, Manufacturing, and Supply Chain to align on regulatory strategies and ensure timely submission of CMC documents.
Communicate and collaborate with external partners, contract manufacturers, and consultants to ensure regulatory compliance and alignment with corporate objectives.
Strong ability to communicate at all levels with clarity and precision.
Regulatory Intelligence & Compliance
Stay current with global regulatory guidelines, standards, and industry practices relevant to CMC, assessing their impact on ongoing projects.
Provide guidance and risk assessments on CMC regulatory matters to senior management and other stakeholders.
Monitor and assess CMC regulatory compliance to ensure continuous alignment with regulatory expectations throughout the product lifecycle.
Documentation & Project Management
Ensure all CMC documentation is accurate, complete, and in compliance with regulatory requirements.
Lead project teams in the development of regulatory documents, timelines, and deliverables, ensuring efficient execution and clear communication of progress and challenges.
Conduct periodic reviews of CMC documentation and processes to drive improvements and ensure adherence to best practices.
Qualifications:
Advanced degree (Ph.D., MS, or equivalent) in chemistry, pharmaceutical sciences, or a related field.
8+ years of experience in Regulatory Affairs with a focus on CMC in the biotech or pharmaceutical industry.
In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH) relevant to CMC.
Proven experience with successful CMC regulatory submissions and post-approval activities.
Demonstrated track record of successful approvals and extensive regulatory agency liaison experience is essential.
Strong project management and organizational skills, with attention to detail.
Excellent written and verbal communication skills, with the ability to present complex information clearly.
Contact: arawat@judge.com
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