Job Description

Regulatory Affairs Egypt, Sudan and Libya

• Lead of our Company’s AH Regulatory Affairs Team Egypt, Sudan and Libya
• Coordination of all regulatory activities for vaccines, pharmaceuticals and insecticides for Egypt, Sudan and Libya in cooperation with NASES business operations and the Global Regulatory department. This includes timely preparation and submission of new registrations and all other related regulatory submission e.g. variations, renewals to the authorities.
• Responsible for preparation and revision of country-specific packaging material according to the approved registration within the company labelling software ARTIS in close collaboration and in alignment with the business operation.
• Close collaboration with marketing and supply chain during whole product lifecycle and especially during product introduction on the market
• Regulatory review and release of marketing material foreseen for these countries
• Following our Company’s AH Regulatory Affairs policies, procedures, systems and country regulations to ensure that regulatory compliance is maintained
• Responsible for interfacing with global PV, global RA, global Quality, and commercial operations to ensure alignment on issues impacting PV and RA activities.

Quality:

• GDP oversight on NASES company AH controlled warehouses including audit function

• Responsible for the regulatory process of product importations by providing regulatory documentation and facilitate product testing by authorities as deemed necessary.

• Responsible for local batch release into the Egypt market

Pharmacovigilance:

• PV Lead NASES region
• PV DPOC of Egypt, Sudan Libya and PV DPOC deputy for Morocco, Algeria, Tunisia and Saudi Arabia
• Responsible for ensuring the establishment and maintenance of a PV compliant systems within the NASES cluster in line with company’s policies and legislations (including training of all NASES employees)
• Pharmacovigilance support within NASES (PV DPOC support, PV audit support)
• Responsible for interfacing with global PV and NASES commercial operations to ensure alignment on issues impacting PV in the cluster

Compliance / Data privacy:

• Compliance / Data privacy lead NASES region
• Responsible for ensuring the establishment and maintenance of Business compliance and data privacy within the NASES cluster in line with company’s policies and legislations
• Compliance support within NASES daily (e.g. guidance, trainings, system use) and during internal audits
• Responsible for interfacing with global/regional compliance and the data privacy office and the NASES commercial operations to ensure alignment on compliance/data privacy related topics.

Qualification:

• University degree in Veterinary, Chemistry, Biology or Pharmacy.
• At least 10 years of experience in regulatory affairs and Pharmacovigilance, preferable veterinary in Egyp.t
• Prioritising Local experience.
• Strong knowledge about Business compliance and Data privacy.
• Strong leadership, communication, decision making, and problem-solving skills.
• good communication and inter-personal skills.
• good organizational skills and works result driven.
• Excellent team-player skills.
• Good computer skills including knowledge of MS Office.
• Fluent in English (written and spoken).

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):

Required Skills:

Adaptability, Adaptability, Animal Biotechnology, Change Management, Communication, Cross-Cultural Awareness, Data Management, Employee Training Programs, FDA Regulations, Global Product Management, Leadership, Management Process, Pharmacovigilance, Policy Implementation, Product Marketing, Product Testing, Regulations, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Documents, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Regulatory Writing, Strategic Thinking {+ 4 more}

Preferred Skills:

Job Posting End Date:

09/25/2025

*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.