MSD Specialist Regulatory Affairs 

Netherlands, North Brabant 

109599725

Job Description

Specialist, Regulatory Affairs (Poultry)

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.

Major activities ofGlobal Regulatory AffairsBiologicals 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.

The Specialist supports the licensing activities related to new registrations and life cycle management to ensure efficient new licensing, product portfolio maintenance/improvement and regulatory compliance.

Responsibilities

• Acts as first point of contact within GRA for CORAs (representatives) and as intermediate between RA product managers and CORAs.

• Maintains good working relations with the contacts within GRA (Product Managers, Operations, Pharmacovigilance), within local and international and outside Animal Health (3rd party CORAs, Dutch Ministry).
• Sends out dossiers/variation packages to the CORAs and/or competent authorities and ensure timely follow up.
• Arranges required other (legalized) documents, information, and all other items (e.g., samples, test materials) necessary for obtaining and maintaining marketing authorizations.
• Ensure timely availability of the requested documents and materials, in line with the licensing strategy.
• Manages according to schedule all actions for obtaining new or amended translations for centrally authorized products via CORAs including communication with CORAs and EMA on these activities.
• Prepares and manages timely submission of high-quality answers to questions from regulatory authorities during standard licensing procedures; Takes care of licensing questions.
• Communicates new, amended and renewed marketing authorizations including commitments to all stakeholders, checks these data involving, when applicable, subject matter experts (e.g., RA product managers), and enter these data in(to) applicable GRA information systems.
• Supports fulfillment of any regulatory commitment given during a registration procedure.
• Conducts, if applicable, standard licensing procedures with the support of team lead or other experienced licensing staff.
• Prepares overviews of changes in registration requirements of countries and with support to identify trends. Communicates changes/trends to relevant GRA teams and other internal stakeholders.
• Participates (with support) in (small) multi-disciplinary project teams providing licensing input for new product registrations and product maintenance.
• Participates (with support) in the design of optimal submission strategies for licensing procedures.
• Participates (with support) in general GRA projects related to document management system or regulatory database/platforms.

Your profile

• HBO Bachelor or equivalent in preferably Veterinary, (Bio) Chemistry, Biology, or Bio-Medical area. If no Higher Professional education, then proven skills and experience to work at such level.
• At least 1 to 3 years of experience in (veterinary) regulatory affairs, preferably in the field of (veterinary) biologicals.

• Good oral and written command of the English language. Good writing skills.
• Accurate, eye for detail, efficient, pragmatic, flexible, service and compliance minded, able to work under (time) pressure and well-developed cultural awareness.
• Excellent communication skills with ability to explain information and persuades others in accepting straightforward situations.
• Good team player skills.
• Ability to identify (licensing) issues in a range of straight-forward situations, analyze and assess them using standard procedures and propose possible solutions.
• Ability to act pro-actively based on planning information and licensing strategy.

• Knowledge and understanding of country-specific licensing requirements and of general aspects of product development, production and quality control. Ability to apply this for standard licensing issues.
• Ability to gain developed understanding of current internal processes and to contribute to improvement of standard processes.
• With limited support, ability to train colleagues on the job.
• Full proficiency with information systems.

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

Animal Health Division

Current Contingent Workers apply

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