AM- Regulatory Affairs-International

AM- Regulatory Affairs-International

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:

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: Clear and concise written and verbal communication

• Team Leadership & People Management: Ability to lead cross-functional coordination

• Collaboration: Works effectively in a team-based environment