MSD Senior Specialist Regulatory Affairs 

Belgium, Brussels 

772483107

Job Description

Function description
The (Senior) Regulatory Affairs Manager (RAM) has as primary task to take care of the several Regulatory Affairs (RA) activities of the registered veterinary medicinal products for The Netherlands, Belgium and Luxembourg.
For the RAM this means the life cycle management of a group of product registrations of AH Benelux and keeping the marketed commercial packages up to date. This includes submitting dossiers to the relevant local authorities as well as translating and revising the English SPC, Product information leaflet (PIL) and labelling texts of these products to Dutch, French and German.
In addition, the RAM has executive, controlling, guiding and advising tasks in activities that are directly or indirectly related to the registration of its products portfolio. Properly weighing and managing the associated business risks is crucial.
The RAM has contact with stakeholders inside and outside the company, defends the interests of the company and considers the requirements of the law and legislation and the business principles of the company.

The position can be filled hybrid from the Netherlands (Boxmeer) or from Belgium (Brussels).

General RA tasks

• Building and maintaining the necessary knowledge in law and legislation, especially concerning veterinary medicinal products (VMPs).

• Acting as a source of information for internal employees regarding RA topics and law and legislation.

• Participating in general RA, marketing and animal species meetings related to its product portfolio to be aware of marketing and sales activities on one hand and to bring forward relevant RA topics on the other hand.

• Fulfilling the role of first point of contact for a specific area of expertise for the internal organization (BUs) and for external organizations.

• Following AH global procedures and write/review local RA-procedures whenever this is needed.

• Advising the RA Director in a specific area of expertise.

Regulatory tasks:
The RAM is responsible for controlling a group of AH VMPs. This concerns the following tasks:

• Life cycle management including translating the master English SPC, PIL and Labelling text into Dutch, French and German and revision by QRD requirements.

• Doing 4 eyes-principle revisions of SPC, PIL and labelling texts that have been revised.

• Submitting of variations of product registrations.These activities are carried out after initiation by GRA.

• Informing and assisting pharmacovigilance colleagues on changes to the product information and submissions.

• Communication with the BU about the changes that impact the products information.

• Taking care of other country-specific aspects of the RA process.

• Taking care of product introduction tasks.

Promotional tasks:

• The RAM is involved in reviewing and approving promotional items.

Having interest in quality or having already a background in quality is a plus. The Quality tasks involve:

• Assuring GDP compliance as applicable for the AH Benelux activities.

• Supporting GDP in the Netherlands, as well as in Belgium -Assisting the Quality Responsible Person in compliance with quality law and legislation as well as policies and procedures on approval of customers, cold chain management, batch release, returned goods, authorities notification, (mock) recall, deviations, etc.

• Helping with the maintenance of Quality Management Documents (QMDs).

Function requirements

• Bachelor or Master degree in Life Sciences (Biology, Medical Biology, Life Sciences, Veterinary Science, Chemistry, Pharmacy, etc.)

• First years of experience in the area of RA and or Quality, preferably of veterinary medicines

• Strong analytical capabilities

• Stress resistant and firm

• Result and deadline driven

• Compliance and quality driven

• System driven person

• Autonomous and independent worker

• An accurate and systematical way of working

• Pragmatic and flexible team player

• Excellent speaking and writing capabilities of the Dutch and English language

• Good writing capabilities of the French and German language

Current Contingent Workers apply

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