Associate Director Regulatory Affairs

Job Title

Associate Director / Sr. Manager - Global Regulatory Affairs

Department:

Regulatory Affairs

Responsibility:

Africa, Middle East, CIS & Non-EEA

Key Responsibilities:

1. Regulatory Strategy & Planning

• Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.
• Ensure alignment with global regulatory strategy and business priorities.
• Conduct regulatory risk assessment and provide mitigation strategies during planning and execution.

2. Dossier Preparation & Submission

• Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations.
• Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation.
• Ensure submission timelines are met as per business needs and agency expectations.

3. Agency Engagement & Partner Coordination

• Act as the primary point of contact for Health Authorities in these regions.
• Lead technical and administrative discussions with regulatory agencies to facilitate approvals.
• Collaborate with regional distributors/partners for local submissions and regulatory intelligence.

4. Lifecycle Management

• Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting.
• Ensure timely implementation of changes across the region.
• Maintain up-to-date regulatory documentation and databases.

5. Compliance & Intelligence

• Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars.
• Provide periodic update on impact and compliance to regulatory head.
• Support regulatory inspections as needed.

6. Cross-functional Collaboration

• Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities.
• Support business development activities, due diligence, and partnership evaluations for the region.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus.
• 12-15 years of experience in regulatory affairs in the pharmaceutical/biotech industry, at least 5 years’ experience in biosimilars is preferred.
• Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines.
• Experience with regulatory submissions in MENA and CIS countries is mandatory.
• Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements.

Required Skills & Competencies:

• Strong project management and organizational skills.
• Excellent written and verbal communication skills.
• Strategic thinking with attention to detail.
• Proactive, collaborative, and culturally aware.
• Ability to manage multiple priorities in a fast-paced environment.