Senior Director, Regulatory CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic direction and oversight for global CMC regulatory activities across assigned programs and the overall portfolio.

• Develop and implement global CMC regulatory strategies to facilitate clinical development, licensing, and lifecycle management of biologic products.

• Act as the Regulatory CMC representative at senior project team and governance levels, offering strategic counsel to support successful product development and approvals.

• Lead collaborative efforts across CMC, Supply Chain, Quality, and Regulatory Affairs to formulate and align global regulatory strategies and submission plans.

• Supervise the planning, creation, and finalization of high-quality CMC regulatory documents to comply with global regulatory standards.

• Provide executive oversight for internal CMC submission review and approval processes to ensure compliance, quality, and alignment with company objectives.

• Manage regulatory CMC activities concerning Health Authority interactions, including meeting strategies, briefing document supervision, and responses to information requests.

• Ensure proactive evaluation of regulatory impacts associated with CMC changes, deviations, and lifecycle management activities; oversee preparation of relevant regulatory submissions.

• Manage timelines, resource allocation, and prioritization of regulatory CMC activities in line with corporate and development goals.

• Serve as a subject matter expert on global CMC regulations and guidance, providing advice to internal stakeholders regarding regulatory expectations and risk management.

• Identify, spearhead, and implement continuous improvement initiatives to enhance Regulatory CMC processes, systems, and cross-functional effectiveness.

• Escalate critical regulatory risks or compliance challenges to senior leadership and present clear recommendations for resolution.

• Stay updated on global CMC regulatory trends, emerging guidance, and Health Authority expectations, translating these insights into strategic recommendations for the organization.

• Mentor, develop, and lead Regulatory CMC staff, fostering a high-performing and collaborative team culture.

⛳️ Requirements

• Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biochemistry, or a related scientific field is required; advanced degrees (Master’s or PhD) are strongly preferred.

• A minimum of 10 years of experience in Regulatory CMC and/or in the pharmaceutical/biotechnology industry is required, showcasing demonstrated leadership roles.

• Extensive experience with biologic products throughout clinical development and commercialization is required.

• In-depth and comprehensive understanding of FDA, EU, and other global CMC regulatory requirements and expectations.

• Significant experience in preparing and reviewing CMC sections for global regulatory submissions (IND, IMPD/CTA, BLA, MAA, variations, supplements, amendments).

• Strong grasp of global development and registration processes, including IND, CTA, BLA, and MAA pathways.

• Previous experience serving as a regulatory CMC lead during Health Authority interactions.

• Proficient in Microsoft Office applications (Word, Excel) and experienced with electronic document management and regulatory publishing systems.

• Strong analytical, problem-solving, and strategic thinking abilities with a talent for navigating complex and ambiguous environments.

• Exceptional written and verbal communication skills, with the capability to communicate complex regulatory concepts clearly to diverse audiences.

• Proven ability to lead, influence, and collaborate across functions at both operational and senior leadership levels.

• Outstanding organizational skills with the capability to manage multiple, time-sensitive priorities.

• Demonstrated ability to thrive in a fast-paced, demanding, and highly collaborative setting while ensuring attention to detail, confidentiality, and regulatory compliance.

🏝️ Benefits

• Bonus

• Stock

• Benefits

• Other applicable variable compensation