Senior Regulatory Affairs Specialist

Over deze vacature

Responsibilities:

• Contributes to preparation and 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);
• Contributes to preparation and timely submission of high-quality answers to questions from regulatory authorities during licensing procedures;
• Develops and maintains profound knowledge of relevant regulatory requirements;
• Supports the development of regulatory strategies for new and existing biological products;
• Supports the maintenance of the biological product portfolio in the market place by providing expert regulatory advice to stakeholders within the company.

Wat we van jou verwachten

Qualifications:

• University degree or HBO Bachelor (or equivalent) in preferable Veterinary, (Bio) Chemistry, Biology or Bio-Medical area;
• At least three to five years of experience in (veterinary) regulatory affairs, preferably in the field of biologicals;
• Knowledge of or experience with the development and/or maintenance of products for the (veterinary) pharmaceutical industry is an asset;
• Excellent oral and written command of the English language; Excellent writing skills.
• Accurate, efficient, pragmatic, flexible, service- and compliance minded, able to work under (time) pressure, and well-developed cultural awareness;
• Excellent communication skills; ability to interpret and explain (more complex) information and to lead others in straightforward situations;
• Excellent team-player skills;
• Ability to identify more complex (licensing) issues, analyze them, and provide possible solutions;
• Ability to balance attention for detail with capacity to keep overview;
• Developed conceptual knowledge and understanding of country-specific licensing requirements, and of general aspects of product development, production and quality control. Ability to apply this for more complex (licensing) issues;
• · Developed conceptual understanding of internal processes. Ability to initiate improvement of more complex processes;
• · Full proficiency with information systems;
• · Ability to train colleagues on the job.

Wat kun je van ons verwachten

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world. Our business cell lives by 3 principles:

• Best over biggest.
• Collaboration over individualism.
• Values and ethics over rules.

#LI-BG1