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Senior Regulatory Affairs Manager

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A 2 year temporary Regulatory Affairs assignment at a large pharmaceutical company

Het bedrijf / The company

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Boxmeer. The location has approximately 45 employees who are responsible for Marketing, Sales, Distribution and Support.

De functie / The role

As a Senior Regulatory Affairs Specialist your primary purpose is to support the new licensing activities of several major new product ranges, as well as the regulatory maintenance of the existing biological products.
You will be part of a subdepartment in the Global Regulatory Affairs team, which is responsible for the biological product portfolio. Your role is to prepare and manage timely submissions of scientific dossiers, variation, and renewal packages for licensing of new biological products and maintenance of the existing biological products portfolio. You will provide veterinary regulatory expertise for both new product development, as well as product maintenance. Doing so, you will ensure that relevant regulatory requirements are followed by the other relevant departments of the organization. You will also develop regulatory strategies for the biological products (both new and existing). Furthermore, you will provide expert regulatory advice to stakeholders (both within and outside of the organization). In addition, you will develop and maintain contacts with regulatory authorities and prepare and manage timely submissions of answers to questions from these authorities.

Het profiel / Your profile

• M.Sc. required, preferably followed by Ph.D. in Biomedical Sciences.
• Knowledge of the (veterinary) pharmaceutical industry in development and/or maintenance of products.
• Knowledge of (or several years experience in) Regulatory Affairs, preferably within the field of biologicals.
• Flexible and persistent, ability to work under high pressure and meet deadlines.
• Good teamplayer, negotiator and attention to details.
• Knowledge of project management.
• Good communication skills in English (verbal, reading and writing).

Het aanbod / The offer

• A challenging job within a large pharmaceutical company.
• A temporary assignment until the end of December 2022.
• Contract of Derks & Derks Secondment & Interim.

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-088-FMF, to Sandra van Putten: info@derksenderks.nl.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

Tenslotte ..... / Finally ....

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

If this is not quite the position you are seeking, please check http://www.derksenderks.nl/vacatures for other interesting jobs!

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.



Derks & Derks Detachering

Geplaatst op FMF: 01 september 2020

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: WO/academisch / MSc, PhD
Werkervaring: 2-5 jaar, 5-10 jaar, > 10 jaar