Regulatory Affairs Manager

The Senior Regulatory Affairs Manager (RAM) has as primary task to take care of the several Regulatory Affairs (RA) activities of the RA-QA-PV Unit.

For the Reg Affairs Manager this means the life cycle management of a group of product registrations of MSD AH Benelux. This life cycle management involves translation of product information texts and taking care of other country-specific aspects of the RA process. Part of these tasks involve collaboration with RA colleagues from Global RA and consultation with the aCBG-BD, FAGG and Luxemburg authorities. In addition, the RAM has executive, controlling, guiding and advising tasks in activities that are directly or indirectly related to the registration of products. 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.

Role in the organization
The RAM reports to a RA Associate Director of MSD AH Benelux.
Collaboration takes place with other RA team members, colleagues of the other business units of MSD AH Benelux and colleagues from Global MSD AH.

Tasks and Responsibilities
- General RA tasks
- Building and maintaining the necessary knowledge in the area of 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 to be aware of marketing and sales activities on the one hand and to bring forward relevant RA topics on the other hand.
- Investigating possibilities for changing national registration of products at the request of the commercial Business Unit (BU).
- Helping and guiding other RAMs, Sr. Regulatory Affairs Associates (RAAs) and PV Managers (PVMs), e.g. in a specific area of expertise and experience.
- Fulfilling the role of first point of contact for a specific area of expertise for the internal organization (BUs) and for external organizations.
- Following MSD AH global procedures and write/review local RA-procedures whenever this is needed.
- Advising the RA Associate Director in a specific area of expertise.
- Packaging tasks:
The RAM is responsible for keeping the leaflets and packaging materials of certain groups of products up to date. This involves working with the company’s packaging database and involves the following tasks.

These tasks involve collaboration with the relevant colleagues from MSD AH Benelux and the MSD AH Global Regulatory Affairs Operations Label department.
- Promotional tasks:
The RAM is involved in reviewing and approving promotional items. These tasks involve collaboration with the Marketing Managers, Veterinary Scientific Liaisons and BU Directors from MSD AH Benelux.
Function requirements
- Bachelor or Master degree in Life Sciences (Biology, Medical Biology, Life Sciences, Veterinary Science, Chemistry, Pharmacy, etc.)
- Knowledge and experience (1-5 years) in the area of RA, preferably of veterinary medicines
- Strong analytical capabilities
- Stress resistant and firm
- Result driven
- Compliance and quality driven
- An accurate and systematical way of working
- Pragmatic and flexible, team player
- Excellent speaking and writing capabilities of the Dutch/French and English language
- Good writing capabilities of the French/Dutch and German language

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**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R223839