Overview of Role:The Senior Director, Regulatory Affairs, CMC, provides global regulatory leadership and strategic oversight for Chemistry, Manufacturing, and Controls (CMC) activities across the portfolio. This role is accountable for defining and executing global CMC regulatory strategy for biologics (large molecules) throughout all phases of development and commercialization.
The Senior Director partners closely with CMC, Supply Chain, Quality, Technical Operations, and Regulatory colleagues to ensure compliant, high-quality, and timely global submissions. This role leads regulatory CMC strategy for development programs and marketing applications, oversees preparation and maintenance of CMC regulatory filings, and serves as a senior regulatory authority in interactions with global Health Authorities.
Role and Responsibilities: - Provide strategic leadership and oversight for global CMC regulatory activities across assigned programs and the broader portfolio.
- Define and execute global CMC regulatory strategy to support clinical development, licensure, and lifecycle management of biologic products.
- Represent Regulatory CMC at the senior project team and governance levels, providing strategic guidance to enable successful product development and approval.
- Lead cross-functional collaboration with CMC, Supply Chain, Quality, and Regulatory Affairs to develop and align global regulatory strategies and submission plans.
- Oversee the planning, development, and finalization of high-quality CMC regulatory documents to meet global regulatory requirements.
- Provide executive oversight of internal CMC submission review and approval processes to ensure compliance, quality, and alignment with company strategy.
- Lead regulatory CMC activities related to Health Authority interactions, including meeting strategy, briefing document oversight, and responses to information requests.
- Ensure proactive assessment of regulatory impact related to CMC changes, deviations, and lifecycle management activities; direct preparation of associated regulatory submissions.
- Oversee timelines, resource planning, and prioritization of regulatory CMC activities in alignment with corporate and development objectives.
- Serve as a subject matter expert on global CMC regulations and guidance, advising internal stakeholders on regulatory expectations and risk mitigation.
- Identify, lead, and implement continuous improvement initiatives to enhance Regulatory CMC processes, systems, and cross-functional effectiveness.
- Escalate significant regulatory risks or compliance issues to senior leadership and provide clear recommendations for resolution.
- Maintain current knowledge of global CMC regulatory trends, emerging guidance, and Health Authority expectations, and translate these into strategic insights for the organization.
- Mentor, develop, and provide leadership to Regulatory CMC staff, fostering a high-performing and collaborative team environment.
Experience, Education and Specialized Knowledge and Skills: - Bachelor's degree in Chemistry, Pharmacy, Engineering, Biochemistry, or related scientific discipline required; advanced degree (Master's or PhD) strongly preferred.
- 10 or more years of Regulatory CMC experience and/or related pharmaceutical/biotechnology industry experience required, with demonstrated leadership responsibility.
- Significant experience with biologic products across clinical development and commercialization required.
- Deep and comprehensive knowledge of FDA, EU, and other global CMC regulatory requirements and expectations.
- Extensive experience leading preparation and review of CMC sections for global regulatory submissions (IND, IMPD/CTA, BLA, MAA, variations, supplements, amendments).
- Strong understanding of global development and registration processes including IND, CTA, BLA, and MAA pathways.
- Prior experience serving as a regulatory CMC lead in Health Authority interactions.
- Proficiency in Mandarin Chinese (spoken and written) is highly desirable.
- Proficient with Microsoft Office applications (Word, Excel) and experienced with electronic document management and regulatory publishing systems.
- Strong analytical, problem-solving, and strategic thinking skills with the ability to operate effectively in complex and ambiguous environments.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory concepts to diverse audiences.
- Demonstrated ability to lead, influence, and collaborate across functions at both operational and senior leadership levels.
- Exceptional organizational skills with the ability to manage multiple, time-sensitive priorities.
- Proven ability to work effectively in a fast-paced, demanding, and highly collaborative environment while maintaining attention to detail, confidentiality, and regulatory compliance.
This is the pay for this position
Pay Transparency
$203,000-$253,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
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