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Senior Specialist Regulatory Affairs

Boxmeer, Netherlands

Job Description

Are you a scientific expert in veterinary, (bio)chemistry, biological, or biomedical sciences? Do you want to be involved in licensing and developing veterinary vaccines and work in a dynamic and multidisciplinary environment? Join our team in Global Regulatory Affairs Biologicals and be part of licensing and maintaining pharmaceutical and biological animal health products globally. Apply now and take the next step in your regulatory affairs career.

For our site in Boxmeer we are looking for a Senior Specialist Regulatory Affairs.

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 want to know what is needed to license veterinary vaccines, to work in multidisciplinary team 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 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 role:

The Senior Specialist is a member of the RA Poultry species team of product managers within Global RA Biologicals. The product managers have an end-to-end responsibility for all regulatory aspects of a selected subset of the poultry product portfolio (mainly vaccines) including new product registration as well as regulatory maintenance/life cycle management of registered products.

You are responsible for the management of project timeline 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 internal stakeholders (R&D, production, commercial) and will participate in meetings with external stakeholders such as the legal 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 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.

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


Responsibilities

  • Prepare and manage timely submission of high-quality answers to questions from regulatory authorities during licensing procedures.
  • Prepare and manage 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).
  • Participate in meetings with authorities to discuss regulatory and technical aspects for new submissions and answering questions during licensing procedures.
  • Develop and maintain profound knowledge of all relevant regulatory requirements.
  • Support regulatory strategies for new and existing biological products.
  • Actively follow 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.
  • Participate in multidisciplinary product development and maintenance teams, with support of the team lead, to provide regulatory affairs expert know-how to ensure that the relevant regulatory requirements are understood and followed by other departments; new product development and product maintenance are in line with relevant regulatory regulations; regulatory compliance.
  • Support the maintenance of the biological portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company.
  • Support and/or participate in general GRA projects or activities affecting large groups of products (complex variations/line extensions for a group of products).
  • Provide feedback on future regulations, monographs, and guidelines.
  • Provide training and support to other (junior) staff (content-related).

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 to 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

For questions about this vacancy

Please send an e-mail with the vacancy number and job title to the following e-mail address: RecruitmentNL@MSD.com.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/30/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date: 06/30/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID: R294007

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