MSD Product Manager Regulatory Affairs Monoclonal Therapeutics 

Netherlands, North Brabant 

504343902

Job Description

Purpose of the role

In this pivotal position, you will be instrumental in advancing our biologics pipeline candidates. Your primary focus will be on harnessing regulatory expertise to ensure efficient licensing, effective lifecycle management, and adherence to global regulatory standards. You will lead the development and implementation of regulatory strategies that directly influence the success of our monoclonal therapeutics in the US, EU, and beyond. Your strategic oversight and collaborative approach will be critical in navigating complex regulatory landscapes, facilitating product launches, and upholding high standards of quality and compliance.

Main tasks and responsibilities

• Develop and implement comprehensive global regulatory strategies for biologics, ensuring alignment with FDA, USDA, and other relevant agencies across all major regions and international markets. Define and execute the regulatory strategy specifically for monoclonal therapeutics, fostering a deep understanding across project teams.
• Lead and manage the preparation of high-quality scientific dossiers—including quality, safety, and efficacy modules—ensuring timely and accurate submissions for licensing, product variations, and renewals.
• Serve as the primary liaison with regulatory authorities for monoclonal products, addressing technical inquiries, and providing clear, comprehensive responses to facilitate smooth approvals during the licensing process.
• Collaborate with interdisciplinary teams, including CMC Development, Manufacturing, Clinical, and Quality Assurance, to ensure thorough understanding and adherence to regulatory requirements throughout product development and lifecycle management. Continuously monitor compliance with EU and US regulations, integrating insights into project timelines.
• Stay informed on emerging regulatory requirements impacting monoclonal therapeutics, evaluating their potential effects on product development. Collaborate on risk mitigation strategies and support the development of internal processes for high-quality regulatory documentation.
• Foster cohesive regulatory practices by engaging with internal stakeholders (R&D, Manufacturing, and commercial teams) and external partners. Effectively manage project timelines and coordinate with Global Regulatory Affairs teams to ensure timely involvement in regulatory activities.
• Provide expert regulatory insight during multidisciplinary product development discussions, ensuring adherence to EU and US standards. Offer interpretations of regulatory guidelines to enable informed decision-making and compliance adherence.
• Mentor junior team members, sharing regulatory expertise while fostering a culture of continuous learning. Support and promote best practices for CMC regulatory compliance, including change controls and post-marketing commitments.
• Advise on necessary changes to policies and procedures, enhancing regulatory functions and improving compliance impact across the organization.

Your profile

• Advanced degree (BS/MS/Ph.D.) in a scientific discipline such as Biology, Biochemistry, Chemistry, Bioengineering, or Biomedical Sciences (e.g., virology, bacteriology, molecular biology, veterinary sciences).
• Extensive experience in the CMC regulatory function, with a strong track record interacting with key regulatory bodies in the EU (EMA) and US (FDA, USDA) and effectively navigating complex regulatory issues.
• Proficient in regulatory submission and approval processes from product development to commercialization, with a solid background in developing and maintaining CMC regulatory documents specific to the animal health industry.
• Preferred experience in biologics development, particularly with monoclonal antibodies, and thorough knowledge of CMC regulatory guidelines from FDA, EMA, USDA, and other agencies.
• Excellent oral and written communication skills in English, with strong negotiation abilities and a talent for producing high-quality regulatory documents.
• Flexible, detail-oriented, and service-minded, with a proven ability to collaborate effectively within a matrix and multicultural environment.
• Willingness to occasionally travel to the US.

What we offer

This role presents a unique opportunity to leverage your expertise to drive the development of innovative products, enhancing the landscape of animal health biologicals. Be part of a dynamic environment where your skills can make a meaningful impact on the future of animal therapeutics. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance.
• 35,5 days of leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Annual bonus based on own and company performance.
• Travel allowance for commuting.
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

For questions about this vacancyPlease send an email including the vacancy number and job title to the following email address:. Please note that this email address can only be used for inquiries.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.