RA Licensing

Netherlands, Boxmeer
december 11, 2024
Fulltime
V-109657
Competitive
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.

Major 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 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:

Associate Specialist, Regulatory Affairs (Swine/Aqua)

You will become part of the RA swine/aqua species team. The focus of your activities will be supporting new submissions and regulatory maintenance of our vaccine portfolio in countries outside the EU.

The Associate Specialist – Licensing 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 of Licensing managers is all licensing aspects of regulatory submissions of the biological’s product portfolio, including new product registration and regulatory maintenance/life cycle management of approved products. Outside of the US, the licensing manager functions as a key regulatory interface for Regulatory Agencies, Country Operations RA, Regional GRA coordinators, our Company’s Manufacturing Division, and other relevant departments.

The Associate 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 with support 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 the company (CORAs, MMD) – local and international and outside the company (third 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 necessary for obtaining and maintaining marketing authorizations.
• Ensures (with support) 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 (with support); 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 simple licensing procedures with the support of team lead or other experienced licensing staff.
• Communicates changes in registration requirements of the countries to relevant GRA teams and other internal stakeholders.
• Participates with support in general GRA projects related to document management system or regulatory database/platforms

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

• 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.
• Knowledge of or experience in (veterinary) regulatory affairs preferably in the field of (veterinary) biologicals or in (veterinary) pharmaceutical industry is an asset.
• Good oral and written command of the English language. Good writing skills.
• Accurate, eye for detail, efficient, pragmatic, flexible, service and compliance minded and able to work under (time) pressure.
• Good team player skills.
• Potential to work in a multicultural environment.
• Excellent communication skills: ability to communicate information clearly, to ask questions and to check for understanding.
• Ability to use existing procedures to solve routine or standard licensing issues.
• Basic conceptual knowledge and understanding of country-specific licensing requirements and of general aspects of product development, production, and quality control. Ability to apply this with support for standard (licensing) issues.
• Ability to gain basic understanding of internal processes.
• Proficiency with information systems.

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