Adamco Pharm is a fast-growing international pharmaceutical holding Company based in Cairo - Egypt, that is responsible for managing international business through searching for new market opportunities where it can expand the volume of the business.

Adamco Pharm is a commercial pharmaceutical agency with a medical portfolio that surpasses 100 products and more than 150 SKUs.

Adamco Pharm holding owns a group of subsidiaries, as EGY Nile Pharm in Burkina, Niger, and Mali, and Egypt Niger.

VACANCY:

We are recruiting a professional candidate to join the Regulatory Team as per the following details:

• Designation: Regulatory Affairs Specialist
• Location: Adamco Pharm, 6 October, Giza
• Reporting: Regulatory Affairs Manager

Job Purpose:

Successful candidate will be the focal point and interface of Adamco Pharm with the Regulatory Authorities mainly the Ministry of Health ensuring strict adherence to its regulations, guidelines, policies and procedures as of products concern.

A. Essential Duties and Responsibilities:

• Ensure regulatory compliance of products, labels, advertising and promotions as well as adherence to company policies and guidelines.
• Stay abreast of regulatory developments and identify opportunities and implications to the business.
• Collaborate with business partners to ensure that product labeling and advertising are competitive and contribute to optimal marketing of products.
• Respond to written questions form regulatory agencies as necessary.
• Submit and follow-up on approval for product changes with regulatory authorities.
• Maintain regulatory files for International submissions/documents with foundational understanding of the CTD format and requirements.
• Interpret existing or new international regulatory guidelines as they relate to company products, procedures, and policies.
• Prepare/revise regulatory procedures as required.
• Provide input to project teams to assure regulatory authority requirements are incorporated as part of the product development process.
• Assist with product registrations.
• Retrieve guidelines and other regulatory information from the internet and other appropriate sources.
• Attend appropriate regulatory meetings and maintain update on regulatory changes.
• Document and archive these discussions and communicate discussions with internal stakeholders as necessary.