Head of CMC RA
il y a 6 jours
The Head of CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs will lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial phases. This role plays a critical part in ensuring compliance with global regulatory requirements while facilitating product approval and lifecycle management for monoclonal antibody therapies targeting orphan autoimmune diseases. The Head of CMC Regulatory Affairs will also drive the preparation, submission, and maintenance of regulatory dossiers to support global product approvals and ensure alignment with health authority expectations.
Key Responsibilities:
Strategic Leadership & Team Management:
- Lead, mentor, and develop a team of (currently) approximately 25 regulatory professionals involved in CMC regulatory affairs across development, manufacturing, and commercial.
- Develop and implement global CMC regulatory strategies to support product development, registration, and lifecycle management.
- Ensure team alignment with corporate goals, regulatory guidelines, and project timelines while fostering a culture of regulatory excellence and innovation.
Global Regulatory Strategy & Execution:
- Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., IND, IMPD, BLA, MAA) to global health authorities (FDA, EMA, PMDA, etc.).
- Provide strategic regulatory advice to cross-functional teams, including research, process development, manufacturing, and quality, to ensure CMC compliance across all stages of product development.
- Ensure timely interactions and communications with global health authorities, responding to requests for additional information, addressing CMC queries, and leading HA meetings.
Lifecycle Management:
- Oversee post-approval CMC regulatory activities, including managing variations, amendments, and responses to health authority requests for existing products.
- Work closely with manufacturing, quality, and supply chain teams to ensure regulatory compliance during tech transfers, process changes, and commercial manufacturing activities.
- Lead the CMC dossier development process, ensuring robust, high-quality submissions that meet global regulatory standards and timelines.
- Oversee the preparation of module 3 documents, ensuring accurate and complete representation of manufacturing processes, controls, and product quality attributes.
- Collaborate closely with external partners, contract manufacturers, and consultants to ensure alignment and consistency in CMC documentation across the entire development and commercialization process.
Regulatory Intelligence & Compliance:
- Stay current with evolving global regulatory guidelines, trends, and best practices in CMC, especially in relation to biologics, monoclonal antibodies, and orphan indications.
- Proactively assess regulatory risks and opportunities, providing actionable recommendations to mitigate potential roadblocks in regulatory submissions or product approvals.
- Ensure continuous compliance with applicable regulations, including Good Manufacturing Practices (GMP) and ICH guidelines.
Experience:
- 15+ years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry, with a focus on biologics or monoclonal antibodies.
- Proven experience in leading regulatory submissions for orphan drugs or autoimmune diseases is highly desirable.
- In-depth knowledge of global regulatory requirements for CMC, particularly in the US, EU, and other key markets.
- Demonstrated success in interacting with global regulatory agencies and navigating complex regulatory environments.
- Strong leadership skills with experience managing and developing high-performing regulatory teams.
- Excellent written and verbal communication skills, with the ability to convey complex CMC information to cross-functional teams and external stakeholders.
- Exceptional project management skills, with a track record of delivering on-time regulatory submissions in a fast-paced environment.
- Problem-solving mindset with the ability to anticipate regulatory challenges and proactively develop risk mitigation strategies.
Education:
- Advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, pharmaceutical sciences, chemistry, or a related field.
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.
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