Director Global Regulatory Affairs Biologicals Job


Merck
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Post Date: May 13, 2017
Job Type: Full time
Degree Requirement: Ph.D.
Years Experience: 5+
Location: Netherlands - Boxmeer
Job Reference: REG002211
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Description
MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD has a workforce of almost 4500 in the Netherlands at three main sites.

MSD. Be well. For more information, visit our website: www.werkenbijmsd.nl

Introduction
Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological products globally. Global Regulatory Affairs Biologicals is a part of this department and is responsible for the biological product portfolio which consists mainly of vaccines.

Major activities of GRA Biologicals are:

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Providing state of the art dossiers, variation and renewal packages for licensing of new biological products and maintenance of the existing biological product portfolio;

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Providing veterinary regulatory expertise for new product development and product maintenance to ensure that relevant regulatory requirements are understood and followed by other relevant MSD AH departments;

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Developing regulatory strategies for new and existing biological products;

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Maintaining the biological portfolio in the market place by providing expert regulatory advise to stakeholders within and outside the company;

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Developing and maintaining contacts with regulatory authorities;

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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 new Director GRA Biologicals will be the head of the Companion animal/Ruminant team (5 persons), and will report to and support the head of GRA Biologicals in the overall management of GRA Biologicals.

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To direct and be accountable for the regulatory activities for part of the Biologicals portfolio (Companion animals/Ruminants).

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To actively support new development projects or products.

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To facilitate and ensure the timely provision of state of the art dossiers, advice and technical input for efficient new licensing and life cycle management.

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To facilitate and support the work of other RA product managers.

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To maintain and develop a profound knowledge of regulatory requirements for major animal health markets such as the European Union, EU-like countries (e.g. Australia) and the BRIC countries (Brazil, Russia, India and China) in order to design optimal global regulatory licensing strategies aimed at coping with future licensing requirements.

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To ensure regulatory compliance.

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To represent Global Regulatory Affairs at international organisations and meetings in order to play a pivotal role in the development of future veterinary legislation and guidelines.

Skills
Qualifications

Education requirements.

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Academic followed by Ph.D. with relevant experience in biomedical sciences (virology, bacteriology, molecular biology) or veterinary sciences.

Other requirements.

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Five to 10 years’ experience in regulatory affairs preferably within the field of veterinary vaccines;

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Experience in (veterinary) vaccine research, vaccine production or quality control is an advantage;

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Profound knowledge of English speaking and excellent writing skills;

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Strong and effective communicator and negotiator; flexible and persistent personality;

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Good team-player skills;

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Good networker – proven ability to efficiently interact within complex organizations;

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Proven ability to maintain an overview of multiple projects/products;

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Proven ability to work under high pressure and to meet critical timelines;

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People manager skills.

Notes
Information & application
For information about this vacancy please contact Andre Verheul on +31 485 587169 or +31 611044390. Only online applications are accepted. For questions about this process, contact Luc Wijnans, Recruiter on +31 485 58 7204.

MSD Animal Health is not open to acquisition through recruitment agencies.

According to company policy candidates who are successful in being selected for this role will be required to sign a non-compete clause.

Job: Regulatory Affairs Generic Job Title:Director Global Regulatory Affairs Biologicals

Primary Location: EMEA-Netherlands-NB-Boxmeer

Employee Status: Regular

Number of Openings: 1

Company Trade Name:MSD

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