Domnic Lewis has been Mandated to hire for AM- Regulatory Affairs-International
Function / Department: Regulatory Affairs – International Markets
Direct Reports: None
Primary Purpose of the Role:
To ensure the timely preparation, review, and submission of high-quality regulatory dossiers for international markets (ROW and Emerging Markets), while maintaining compliance with global regulatory requirements and facilitating successful product registrations and life cycle management.
Key Responsibilities:
1. Prepare and review CTD and ACTD dossiers for regulatory submissions.
2. Coordinate with Manufacturing and R&D; teams to collect required data and documents.
3. Liaise with manufacturing sites to ensure ongoing regulatory compliance.
4. Ensure timely execution of monthly regulatory submission plans and respond to regulatory queries within deadlines.
5. Conduct gap analyses and update master regulatory data accordingly.
6. Review key regulatory documents including Change Controls, Stability Protocols, Clinical Trial Protocols, and Packaging Artworks.
7. Obtain country-specific feedback for variations and ensure timely submissions.
8. Handle dossier renewals and update master data records.
9.
Conduct regular follow-ups with manufacturing teams for documentation and hold periodic review meetings.
10. Track and review requirements for upcoming regulatory filings across international markets.
Required Knowledge, Skills & Experience:
Education:
M.Pharm / M.Sc. (Biotechnology or related discipline)
Experience:
6–8 years in Regulatory Affairs with experience in international market submissions
Technical Skills:
- Strong knowledge of CTD, ACTD, and eCTD formats
- Familiarity with ICH guidelines and validation requirements
- Experience with regulatory filings for USFDA, EMA, WHO PQ, MCC (South Africa)
- Exposure to in-licensing and out-licensing activities
- Understanding of lifecycle management for biological and biotech products
Behavioral Competencies:
- Planning & Organization: Ability to manage timelines and coordinate multiple projects
- Analytical Thinking: Strong problem-solving and data interpretation skills
- Communication: Transparent and concise written and verbal communication
- Team Leadership & People Management: Ability to lead cross-functional coordination
- Collaboration: Works effectively in a team-based environment