Associate Regulatory Affairs Specialist (CR/521330) Boxmeer, Netherlands Associate Regulatory Affairs Specialist One of our clients in the biotech industry is looking for an Associate Regulatory Affairs Specialist.

The role is contract-based for initially 1 year, starting March 2025, for 40 hours per week.

The office is located near Nijmegen, with a Hybrid working policy currently in place.

The Global Regulatory Affairs (GRA) Department is accountable for licensing and maintaining pharmaceutical and biological animal health products globally.

GRA Biologicals is a part of this department and is responsible for the biological product portfolio.

We have an exciting opportunity at the Boxmeer facility for an Associate Regulatory Affairs Specialist.

You will become part of the RA swine/aqua species team, focusing on supporting new submissions and regulatory maintenance of our vaccine portfolio in countries outside the EU.

The RA species teams have end-to-end responsibility for all regulatory aspects of their species product portfolio, including new product registration and regulatory maintenance/life cycle management of registered products.

Responsibilities: Act as the first point of contact within GRA for CORAs (representatives) and as an intermediary between RA product managers and CORAs.

Maintain good working relations with contacts within GRA (Product Managers, Operations, Pharmacovigilance), within the company (CORAs, Manufacturing), and outside the company (third-party CORAs, Dutch Ministry).

Send out dossiers/variation packages to the CORAs and/or competent authorities and ensure timely follow-up.

Arrange required documents and information necessary for obtaining and maintaining marketing authorizations.

Ensure timely availability of the requested documents and materials in line with the licensing strategy.

Manage actions for obtaining new or amended translations for centrally authorized products via CORAs, including communication with CORAs and EMA.

Prepare and manage timely submission of high-quality answers to questions from regulatory authorities during standard licensing procedures.

Communicate new, amended, and renewed marketing authorizations to all stakeholders and enter this data into applicable GRA information systems.

Support fulfillment of any regulatory commitment given during a registration procedure.

Conduct standard simple licensing procedures with the support of team lead or other experienced licensing staff.

Communicate changes in registration requirements of the countries to relevant GRA teams and other internal stakeholders.

Participate in general GRA projects related to document management systems 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.

Knowledge of or experience in (veterinary) regulatory affairs, preferably in the field of biologicals or in the pharmaceutical industry.

Good oral and written command of the English language with good writing skills.

Accurate, detail-oriented, efficient, pragmatic, flexible, service, and compliance-minded with the ability to work under pressure.

Good team player skills with the 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 of country-specific licensing requirements and general aspects of product development, production, and quality control.

Ability to apply this knowledge with support for standard licensing issues.

Proficiency with information systems and ability to gain a basic understanding of internal processes.

Details: Project length: 1 Year, with the option to extend or move to FTE for the right candidate Apply Now Are you the Associate Regulatory Affairs Specialist we’re looking for? Please contact Tom van Marsbergen via +31 (0)20 522 1588 or t.vanmarsbergen(@)realstaffing.com #J-18808-Ljbffr