Technical Director

About the Role

The role involves overseeing regulatory strategy and compliance, ensuring that all products meet national and international standards while managing pharmaceutical processes effectively.

Responsibilities

Regulatory Strategy & Compliance:

• Develop and implement regulatory strategies to ensure compliance with Algerian health authority regulations (Ministry of Health, National Agency of Pharmaceutical Products, etc.).
• Ensure all products adhere to national and international regulatory standards.
• Stay updated on new regulations, guidelines, and changes in the regulatory landscape, applying this knowledge to both regulatory processes.
• Oversee product registration, licensing, and the submission of regulatory dossiers, incorporating technical expertise.

Regulatory Submissions & Approvals:

• Manage and oversee the preparation, submission, and follow-up of regulatory dossiers, ensuring all necessary technical information is included.
• Collaborate with production teams to prepare documentation required for regulatory approvals, such as product specifications, process validation reports, and batch records.
• Liaise with regulatory authorities to negotiate and secure product approvals in a timely manner.

Cross-functional Collaboration:

• Collaborate with R&D, Quality Assurance, Manufacturing, and Sales teams to integrate regulatory compliance into product development and commercialization processes.
• Provide regulatory and technical guidance during product development and market expansion.

Team Management & Leadership:

• Lead and manage both the Regulatory Affairs team, providing mentoring, strategic direction, and career development opportunities.
• Foster collaboration across teams to ensure regulatory objectives are met efficiently.

Stakeholder & Government Relations:

• Establish strong relationships with regulatory authorities (Ministry of Health, National Agency of Pharmaceutical Products, etc.) and other relevant bodies.
• Serve as the main point of contact for government bodies regarding regulatory related inquiries.
• Represent the company in regulatory and industry forums, leveraging both regulatory and technical expertise.

Regulatory Intelligence & Risk Management:

• Monitor regulatory trends and changes in the pharmaceutical industry and assess their impact on regulatory strategies.
• Conduct risk assessments, ensuring that regulatory compliance efficiency are maintained.
• Prepare the company for regulatory audits and inspections by ensuring the regulatory teams are compliant.

Qualifications

• Education:
  Advanced degree in Pharmacy, Life Sciences, or a related field.
• Experience:
  Minimum of 5-10 years in Regulatory Affairs with at least 3 years in a Pharmacist Production Technical Director role.
• Languages:
  Fluency in Arabic, French, and English (spoken and written).

Equal Opportunity Statement

We are an equal opportunity employer and are committed to creating a diverse and inclusive workplace. We encourage applications from all qualified individuals regardless of race, gender, age, sexual orientation, disability, or any other characteristic protected by law.