Associate Director Global Regulatory Affairs (Biologicals)

Job Description

Did you always want to work in a company where your work can have a real impact? Do you enjoy working in an international environment with lots of room for personal development?

Welcome in our team

Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological animal health products globally. GRA Biologicals is a part of this department and responsible for the biological product portfolio.

Do you have a strong scientific background in veterinary, (bio)chemistry, biological or biomedical sciences? Are you interested in leading a small team? Do you want to know what is needed to license veterinary vaccines and to work in multidisciplinary teams in a dynamic environment? Then we want to invite you to apply for this position.

We have an exciting opportunity at the Boxmeer facility for a: Associate Director Regulatory Affairs (RA)

About the role

The Associate Director will be a member of the RA Companion Animals and Ruminant species team within GRA Biologicals. The RA Companion Animals and Ruminant species team consists of Product managers and Licensing managers and has end-to-end responsibility for all regulatory aspects of the Companion Animals and Ruminant product portfolio (mainly vaccines) including new product licensing as well as regulatory maintenance/life cycle management of licensed products.

The team provides the technical content of regulatory submissions and its members function as the main point-of-contact for the Animal Health internal stakeholders (R&D, production, commercial) and participate in meetings with external stakeholders such as competent authorities.

The RA species team is also responsible for the management of project timelines associated with regulatory activities including proper and timely involvement of other GRA teams/functions needed for these activities.

The Associate Director is the driver of new licensing and life cycle management activities from a RA point of view to assure efficient new licensing, product portfolio maintenance/improvement, and regulatory compliance.

This role has major impact on the performance of the Global Regulatory Affairs (GRA) department and the company in relation to licensing of new products and regulatory maintenance of our existing product portfolio.

GRA Biologicals provides you a challenging environment where you will get the opportunity to broaden your skills as regulatory affairs professional or to develop into one.

Activities:

• Providing state of the art dossiers, variation, and renewal packages for licensing of new biological products and maintenance of the existing biological product portfolio.
• Providing veterinary regulatory expertise for new product development and product maintenance to ensure that relevant regulatory requirements are understood and followed by other relevant departments.
• Developing regulatory strategies for new and existing biological products.
• Maintaining the biological portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company.
• Developing and 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.

Responsibilities:

• Prepares and manages timely submission of high-quality state of the art scientific dossiers for efficient licensing of new products and maintenance of existing products (i.e., variations, renewals).
• Prepares and manages timely submission of high-quality answers to questions from regulatory authorities during licensing procedures.
• Visits authorities to discuss regulatory and technical aspects for new submissions and answering of questions during licensing procedures.
• Develops and maintains profound knowledge of all relevant regulatory requirements.
• Develops regulatory strategies for new and existing biological products.
• Actively follows the development/emergence of new regulatory requirements, to assess their potential impact for new product development and product maintenance and to develop regulatory strategies to cope with future requirements.
• Participates in multidisciplinary product development and maintenance teams to provide regulatory affairs expert know-how to ensure that relevant regulatory requirements are understood and followed by other Animal Health departments and that new product development and product maintenance is in line with relevant regulatory regulations.
• Maintains the biological portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company.
• Participates or takes the lead in general GRA projects.
• Participates in regulatory expert groups within the veterinary pharmaceutical industry associations to play a role in the development of future veterinary legislation and guidelines.
• Manages a small team.

Your profile

• University degree or HBO Bachelor (or equivalent) in preferable Veterinary, (Bio) Chemistry, Biology or Bio-Medical area.
• At least three to five years of experience in (veterinary) regulatory affairs, preferably in the field of biologicals.

• Knowledgeable regarding the development and/or maintenance of products for the (veterinary) pharmaceutical industry is needed.
• Fluent in the English language.
• Accurate, efficient, pragmatic, flexible, service- and compliance minded, able to work under (time) pressure.
• Able to balance attention for detail with capacity to keep overview.
• Developed conceptual knowledge and understanding of country-specific licensing requirements, and of general aspects of product development, production, and quality control. Able to apply this for more complex (licensing) issues.
• Ability to lead a small team and train people.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive:

• Competitive salary
• 35,5 days of leave
• Attractive collective health care insurance package with considerable reduction rates
• Solid Pension Plan
• Bonus plan subject to the company annual results
• Flexible working arrangements (hybrid workplace)

Animal Health Division

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We 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 our customers, consumers, animals, society, and our planet. We offer 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.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines, and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R233470