Regulatory Affairs Manager

Company Description:

Pharmacon Association, a well-known Egyptian pharmaceutical company has a diverse portfolio of marketing authorization licenses for registered and under-registration local and imported pharmaceutical products (Human, Biological, Medical devices, Food supplement and Cosmetics) for diverse reputable European international companies in Germany, Italy, Switzerland, Spain and Romania

Location: Nasr City,Cairo

Role Description

• Manage, coordinate the execution of the regulatory plans ensuring close follow up with the licensors and timely reporting.

• Preparation and submission of registration dossiers, variations, renewals, and relevant activities, ensuring timely execution.

• Ensure compliance of product labeling, packaging, with local regulations and internal policies. 

• Monitors timelines for key submissions for all types of products; pharmaceuticals, biological, medical devices, food supplement and cosmetics.

• Manage the execution of registration of local pharmaceuticals, food supplements, cosmetics at EDA and NFSA.

• Manage, prepare, submit and follow up the importation license, importation plans & approvals, lot release documentation, custom medical release, inspection release for all type of products.

• Manage, prepare, submit and follow up the importation license, plans, lot release documentation, custom medical release, inspection release for all type of products.

• Ensure effective cross functional coordination across company departments Regulatory, Quality and Commercial, to maintain supply continuity and patient access.

• Liaison and support between regulatory authorities and functioning departments of the company.

• Contribute to the development, improvement and expansion of the company`s portfolio and related project management.

⬇️ Qualifications:

• Bachelor's degree in Pharmacy.

• Minimum of 4 years of experience in a similar position.

• Fluency in English, both written and verbal are a must.

• Good understanding of regulations and related guidelines.

• Familiarity with different regulatory dossiers (CTD, eCTD) is a must.

• Strong personality, organizational skills and ability to plan and manage own work agenda independently.

• Ability to collaborate effectively.

• Strong interpersonal communication and organizational skills.

• Ability to establish and maintain effective

. working relationships with coworkers, managers, and clients.

• Ability to collaborate effectively.