Director Regulatory Affairs Poultry (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 (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.
The Director Regulatory Affairs Poultry will report to and support the Head of GRA Biologicals in the overall management of GRA Biologicals.
As Director Regulatory Affairs Poultry 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).
• Manages the RA product manager team with respect to resource allocation, budget, workload for individual staff (3 to 5 staff), performance, and priority setting for the team in line with overall business priorities;
• Ensures that all direct reports have clear priorities and personal development plans;
• Ensures the timely submission of high-quality dossiers and answers to questions for efficient licensing of new products and maintenance of existing products (i.e. variations, renewals) in close cooperation with the project teams as well as other regulatory groups (licensing, dossier building, artwork management);
• Keeps oversight of the status of new development and life cycle management projects of the RA product managers team including required GRA resources;
• Takes an active role in setting up efficient roll out strategy for (new) products in the various markets, provides regulatory input on portfolio rationalization strategy and contribute to Value Chain activities;
• Communicates effectively with stakeholders to ensure that GRA timelines and activities meet business expectations
• Develops and maintains profound knowledge of all relevant regulatory requirements and takes the lead in the development of regulatory strategies for new and existing biological products in view of costs, resources, time-to market while considering the changing regulatory environment, the company’s objectives and the business plans of all stakeholders;
• Develops and maintains contacts with regulatory authorities and visits authorities to discuss regulatory and technical aspects of licensing procedures;
• Participates directly in a limited number of multidisciplinary product development and maintenance teams to provide regulatory expertise ;
• Ensures regulatory compliance by setting the appropriate standards for RA product managers and escalation of appropriate issues to higher management;
• Takes the lead or participates in general GRA projects including e.g. documentation system or regulatory database or GRA activities affecting large groups of products (complex variations/line extensions);
• Plays a pivotal role in the development of future veterinary legislation by providing feedback on future regulations, monographs and guidelines and representing GRA at international organizations and meetings (with authorities);
• Provides training and support to other (junior) staff and other relevant departments.
• Five to ten years of experience in the (veterinary) pharmaceutical industry in the development and/or maintenance of products, and in regulatory affairs, preferably in the field of biologicals.
• Excellent oral and written command of the English language. Excellent writing skills;
• In-depth knowledge and understanding of regulatory requirements with focus on content of dossiers;
• In-depth knowledge and understanding of general aspects of product development, production and quality control preferably with biologicals
• Strong and effective communicator and negotiator. Cultural empathy;
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