Sr Director - CMC Regulatory Affairs

Senior Director, CMC Regulatory Affairs

The Senior Director, CMC Regulatory Affairs is responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities for Merus’ product candidates, from the transition from Research to Development through to product licensure.

The role will be responsible for the oversight and leading the development and implementation of CMC regulatory strategies, ensuring timely and compliant regulatory submissions, and managing the coordination of internal and external CMC regulatory activities, including those related to co-development partnerships.

Your Role:

This role requires significant expertise in regulatory affairs for biologics and/or bio-pharmaceuticals, with a deep understanding of global regulatory frameworks (EU/US), GMP, GLP, GCP, GDP, and GRP. The Senior Director will work cross-functionally to ensure seamless integration of CMC regulatory strategies into development programs, enabling the timely progression of clinical trials and product development. This position is based in Utrecht, the Netherlands.

Areas of Full Responsibility:

• Preparation, Review, and Approval of CMC Regulatory Filings: Lead the preparation and regulatory submission of CMC sections for regulatory filings (e.g., IMPD/IND/MAA/BLA). Ensure all submissions are accurate, compliant, and submitted in a timely manner.
• Oversee CMC Regulatory Affairs Strategy: Jointly develop and implement CMC regulatory strategies for Merus’ product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
• Management and Coordination of CMC Regulatory Activities: Oversee and coordinate all internal and external CMC regulatory activities related to Merus’ product candidates, including activities with external partners and contractors, and those in co-development or partnership.
• Contractor Selection and Performance Monitoring: Lead the selection, evaluation, and monitoring of contractors for CMC regulatory affairs activities. Ensure contractors meet quality and performance standards, managing relationships to ensure timelines and deliverables are met.

Areas of Support:

• Defining CMC Regulatory Affairs Strategy: Jointly develop the CMC regulatory strategies for Merus’ product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
• Regulatory Affairs Department Creation: Work in cooperation with Clinical Regulatory Affairs to establish and support a regulatory affairs department.
• Approval of CMC Regulatory Affairs Contractors: Support the approval process for contractors and vendors involved in CMC regulatory activities.

Key Activities:

• Status and Planning Reporting: Regularly report on the status and planning of CMC regulatory affairs dossiers and submissions to internal stakeholders, ensuring proactive communication of timelines, milestones, and potential risks.
• Manage and coach: Lead and mentor the CMC- RA team, which consists of 3 team members, working collaboratively to achieve goals.
• Conflict Management and Escalation: Ensure any conflicts between Merus and external contractors/vendors related to CMC regulatory affairs are identified, addressed, and escalated as necessary to ensure timely resolution and project success.

Your Profile:

• MSc or PhD in Life Sciences, Bio-engineering, or a related field.
• At least 12 years of relevant working experience within the (bio)pharmaceutical industry or in other relevant regulatory functions, with strong expertise in CMC regulatory affairs.
• Proven experience in CMC regulatory submissions (IND/IMP/MAA/BLA) for both biologic products and small molecules.
• In-depth knowledge of Regulatory Affairs in the EU and US markets, with a strong understanding of relevant regulatory frameworks.
• Extensive knowledge of GMP, GLP, GCP, GDP, and GRP guidelines and regulations.

Skills and Competencies:

• Strong leadership and project management skills with the ability to coordinate and manage multiple cross-functional teams, including external contractors and partners.
• Ability to think strategically and contribute to the development of CMC regulatory strategies.
• Excellent communication and interpersonal skills, with the ability to collaborate across functions and manage regulatory relationships with external stakeholders.
• Strong problem-solving and decision-making skills, with the ability to handle complex regulatory issues effectively.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Why Merus?

This is a critical role in a fast-growing company that offers the opportunity to influence the regulatory strategy for innovative biologics. As a Senior Director in CMC Regulatory Affairs at Merus, you will play a key role in advancing groundbreaking therapies to treat cancer and other serious diseases. You’ll have the chance to make a significant impact on both the development of new treatments and the long-term success of the organization.

The position is based in Utrecht, the Netherlands, offering a dynamic and supportive work environment with the opportunity to collaborate on a global scale.