Domnic Lewis has been Mandated to hire for Manager- Regulatory Affairs-International
Primary Purpose of the Role:
To manage and oversee the preparation, review, and timely submission of regulatory dossiers in CTD and ACTD formats for international markets, while ensuring ongoing regulatory compliance and supporting product lifecycle management across ROW and emerging markets.
Key Responsibilities:
1. Prepare and review Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers.
2. Coordinate with manufacturing sites and R&D; to gather necessary data and documents for regulatory submissions.
3. Ensure plant compliance with regulatory requirements and facilitate timely implementation of changes.
4. Meet monthly regulatory submission targets and respond to queries within specified timelines.
5. Perform gap analysis and regularly update master regulatory data.
6. Review regulatory-related documents including Change Controls, Stability Protocols, Clinical Trial Protocols, and Artwork.
7. Gather feedback from international markets on variations and ensure their timely submission.
8. Manage dossier renewals and maintain up-to-date master documentation.
9. Conduct regular follow-ups with manufacturing units for required documentation and participate in review meetings.
10. Track,
compile, and review documents for upcoming product filings in ROW and emerging markets.
Required Qualifications & Experience:
Education:
- M.Pharm / M.Sc. in Biotechnology or related field
Experience:
- Minimum 6–8 years of experience in Regulatory Affairs, with a strong focus on international market submissions
Technical Knowledge & Skills:
- Expertise in CTD, ACTD, and eCTD dossier formats
- In-depth knowledge of ICH guidelines and regulatory validation requirements
- Familiarity with international regulatory filings including USFDA, EMA, WHO Prequalification, and MCC (South Africa)
- Experience in handling regulatory submissions for biological and biotech products
- Exposure to both in-licensing and out-licensing of regulatory dossiers
Core Competencies:
- Planning & Organization – Effectively manages time and priorities to meet deadlines
- Analytical Thinking – Strong attention to detail and problem-solving skills
- People Management – Ability to lead cross-functional collaborations (where applicable)
- Communication – Strong written and verbal communication for internal and external coordination
- Team Leadership – Works well in a cooperative environment, taking initiative where needed