(Senior) Specialist, Regulatory Affairs

Job Description

R321324 (Senior) Specialist, Regulatory Affairs

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 Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R321324