Director Regulatory Affairs / Licensing (Global)
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. They are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. They are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
Animal Health Division
The Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. They are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards their customers, consumers, animals, society and the planet. MSD Animal Health offers one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.
The Global Regulatory Affairs Department Biological is looking for a:
Director Regulatory Affairs / Licensing
He or she will report to and support the Head of GRA Biologicals in the overall management of GRA Biologicals.
The Global Regulatory Affairs (GRA) department is accountable for licensing and maintaining pharmaceutical and biological products globally.
Global Regulatory Affairs Biologicals is a part of this department and is responsible for the biological product portfolio.
Major activities of GRA Biologicals are:
• Licensing of new biological products by providing state of the art dossiers.
• Participating in new product development teams to ensure that regulatory requirements are understood and followed.
• Developing regulatory strategies for new and existing biological products.
• Maintaining the biological portfolio in the market place by providing expert regulatory advice to stakeholders within and outside the company.
• Maintaining contacts with regulatory authorities.
• Participating in regulatory expert groups within the veterinary pharmaceutical industry association(s) to play a role in the development of future veterinary legislation and guidelines.
In addition, GRA Biologicals participates in the development of future veterinary regulatory legislation and guidelines. This is achieved in close collaboration with R&D, the manufacturing and commercial company‘s AH organization. The design of optimal global regulatory strategies and provision of high-quality dossiers, advice and technical input are prerequisites for efficient new licensing and life cycle management.
As Director RA/Licensing you will be responsible for a team of professionals that plays a key-role in the licensing of new biological products and the regulatory maintenance of the existing Biological product portfolio globally (except for the United States).
• Manage the licensing team of GRA Biologicals by ensuring proper resource allocation and priority setting for the team (12 to 15 staff) in line with overall business priorities;
• Ensure timely submission and appropriate follow-up of new product applications as well as regulatory maintenance of previously authorized products including variations, renewal applications and supplemental marketing authorizations;
• Keep oversight of European and International licensing activities for new and existing products in alignment with the company’s strategy and objectives;
• Function as the key regulatory interface for the Country Regulatory Affairs representatives (CORAs), regional RA coordinators, regional management, manufacturing and other company departments, as relevant.
• Develop regulatory submission strategies with (internal) stakeholders to ensure optimal new product licensing and regulatory product maintenance in view of costs, resources and time to market in designated countries;
• Pursue developments of regulatory legislation and requirements with a focus on licensing aspects. Identify new and emerging requirements, evaluate their potential impact on licensing aspects and regulatory (submission) strategies for the Biologicals product portfolio and communicate them to relevant departments.
• Monitor the regulatory compliance status in the countries concerned;
• Ensures that regular trainings are provided to other functions e.g. CORAs on relevant GRA procedures and systems;
• Participate in industry association committees and initiatives as regulatory expert to represent and defend the company’s interest e.g. Animal Health Europe.
• Ensure that all direct reports have clear objectives and personal development plans
• Master degree in Biomedical sciences (virology, bacteriology, molecular biology) or veterinary sciences, preferably followed by Ph.D. (or equivalent experience).
• 5 to 10 years’ experience in regulatory affairs preferably within the field of veterinary vaccines.
• In depth knowledge and understanding of regulatory requirements.
• Knowledge and understanding of the general aspects of product development, production and quality control preferably with Biologicals.
• Excellent oral and written command of the English language.
• Strong and effective communicator and negotiator, cultural empathy.
• Pro-active, pragmatic, flexible and persistent personality; Service and compliance-minded;
• Good team-player skills.
• Good networker – proven ability to efficiently interact within complex organizations.
• Proven ability to maintain an overview of multiple projects/products.
• Proven ability to work under high pressure and to meet critical timelines.
• Proven people manager skills.
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive
• Competitive salary
• Company car
• Attractive collective health care insurance package with considerable reduction rates
• Solid Pension Plan
• Bonus plan subject to the company annual results
• Flexible working arrangements
Marjo Lucker | Recruitment Consultant
+31 - 6 - 13 56 19 88 | firstname.lastname@example.org
Marije Hoogendoorn | Sr. Recruitment Specialist
+31 - 6 - 23 13 51 18 | email@example.com