Regulatory Affairs Specialist- Animal Health

Merck Gruppe - MSD Sharp & Dohme; Riyadh; On-site; SAR 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Specialist to handle Marketing Authorization applications and maintain product compliance. The ideal candidate will have a degree in pharmacy or life sciences and relevant experience, demonstrating strong communication and organizational skills. This role involves collaboration with internal teams and regulatory bodies to ensure timely submissions and approvals, making it essential for those looking to advance their career in a dynamic environment.

Qualifications

• 1-2 years of experience in the pharmaceutical industry, preferably in regulatory, medical, or laboratory positions.
• Ability to communicate well verbally and in writing.
• A client-oriented approach and work according to company vision.

Responsibilities

• Prepare and submit Marketing Authorization applications to local authorities.
• Maintain authorized products and submit variations and renewals.
• Manage labeling translation and artwork.

Skills

Detail-Oriented

Good Organizational Skills

Communication

Flexibility

Education

Degree in Pharmacy or Life Sciences

Tools

Regulatory Affairs Compliance

Pharmaceutical Management

Job description

Job Description

Bring energy, knowledge, innovation to carry out the following:

(may not be limited to):

• Ensure timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
• Ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures high quality labelling translation andartwork management.
• Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new regulations, in cooperation with other internal stakeholders.
• Stay updated on relevant EU and local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts on sub-regional, regional and global level, our Manufacturing Division, EUQPPV and GSC&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Must hold a degree in pharmacy or otherlife scienceor equivalent. An approx. minimum of 1-2 years’ experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
• Ability to communicate well verbally and in writing, good organizational and planning skills, a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work
• A sound appreciation of the interactions and relationships with other groups internally, a client-oriented approach and work according to the company leadership vision

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Art Handling, Biological Sciences, Biomedical Sciences, Biostatistics, Business, Clinical Pharmacy, Detail-Oriented, Immunochemistry, Innovation, Life Science, Management Process, Pharmaceutical Management, Product Approvals, Regulatory Affairs Compliance, Reproductions

Preferred Skills:

Job Posting End Date:

07/24/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R357103