Scientific & Regulatory Affairs Manager

– North Africa

The primary responsibility of the Scientific & Regulatory Affairs Manager – North Africa in AcedrA BioPharmaceuticals is ensuring that products such as pharmaceuticals, and medical devices meet legislative requirements and overseeing the market access efforts in Tunisia, Libya, Algeria, and Morocco.

Key duties of the job include: studying scientific and legal documents. gathering, evaluating, organizing, managing, and collating information in a variety of formats.

Main Responsibilities include:

• Ensure approval of registration applications of all medicines in applicable countries.
• Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations, and guidelines
• Compilation of registration dossiers for submissions
• Ensure that the local Regulatory Affairs unit applies the latest Procedures and Guidelines as published.
• Ensure that the applicable country-specific Fees are paid on time.
• Ensures that the overall corporate databases for these countries are kept up to date.
• Perform QA on all artwork and approve all printed packaging material
• Ensure compliance with quality requirements on the release of medicine for sale in line with GMP and AcedrA policies and procedures.
• Prepare and update data for all marketed products in liaison with the other departments
• Establish and maintain effective relationships with all stakeholders
• Engage his/her diploma with the local regulatory authority and ensure the business continuity

Requirements

• •Pharmacsit/ Veterinary/Dentist/Medical Doctor or equivalent degree
• •Registration with Tunisian local authority of Pharmacy/Veterinary/Dentistry/Medicine
• •Good analytical, organizing, and communication skills.
• •Self-starter, able to work independently
• •Able to handle multiple projects simultaneously.
• •Fluency in English is a preference.
• •Persistent, hardworking, goal-driven
• •Able to handle multiple priorities
• •Strategic thinker