Senior Specialist Global Regulatory Affairs Biologicals

Job Description

Do you have a strong background in biomedical sciences and do you think that a career in regulatory affairs is the next step for you? Do you always want to work in an international company where your work can have a real impact on the well-being and life of animals, please consider applying for this exciting function

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? Do you always wanted to know what is needed to license veterinary vaccines, to work in multidisciplinary teams in a dynamic environment, then we invite you to apply for this position.

M ajor activities of Global Regulatory Affairs Biologicals are:

• 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 Animal Health 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.

We have an exciting opportunity at the Boxmeer facility for a:

Senior Specialist, Regulatory Affairs (Companion Animals/Ruminants)

The Senior Specialist - RA Product Manager will be a member of a RA species team within Global RA Biologicals. GRA Biologicals has a RA poultry, swine/aqua and companion animal/ruminants species team. The RA species teams have end-to-end responsibility for all regulatory aspects of its species product portfolio (mainly vaccines) including new product registration as well as regulatory maintenance/life cycle management of registered products. The RA species teams are 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 main area of responsibility for the RA product managers is the technical content of regulatory submissions and its members function as the main point-of-contact for Animal Health's internal stakeholders (R&D, MMD, commercial) and will participate in meetings with external stakeholders such as competent authorities.

The senior specialist participates in driving the new licensing and life cycle management activities from a RA point of view to ensure efficient new licensing, product portfolio maintenance/improvement, and regulatory compliance.

The work of Senior Specialist - RA Product manager has substantial impact on the performance of the GRA department and the company in relation to licensing of new products and regulatory maintenance of existing product portfolio.

Global Regulatory Affairs - 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.

• 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.
• Participates in visits to 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.
• Supports the development of regulatory strategies for new and existing biological products.
• Actively follows the development/emergence of new regulatory requirements, to support the assessment of their potential impact for new product development and product maintenance and to develop regulatory strategies to cope with future requirements.
• Participates with support of the team lead in multidisciplinary product development and maintenance teams to provide veterinary regulatory expertise to ensure:
  • That relevant regulatory requirements are understood and followed by other Animal Health departments,
  • New product development and product maintenance is executed in line with relevant regulatory regulations,
  • Regulatory compliance is maintained.
• Supports the maintenance of the biological product portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company.
• Supports general GRA projects (e.g., Alexx,) or GRA activities affecting large groups of products (complex variations/line extensions for a group of products).
• Provides feedback on future regulations, monographs, and guidelines.
• Provides training and support to other (junior) staff (content-related).

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.

Your profile

• Academic education followed preferably by Ph.D. (or equivalent experience) in biomedical sciences (e.g., virology, bacteriology, molecular biology, veterinary sciences).
• Knowledge of or several 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 is an asset.
• Excellent oral and written command of the English language. Excellent writing skills.
• Effective communicator and negotiator.
• Flexible and persistent personality. Service and compliance minded.
• Good team player skills.
• Ability to work under high pressure and to meet deadlines.
• Ability to work in a matrix and multi-cultural environment.
• Attention for details.
• Basic knowledge of project management.

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

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R266759