Am- Regulatory Affairs-international

4 days ago

Mumbai Maharashtra, India Domnic Lewis Pvt. Ltd Full time

**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**:

- Prepare and review CTD and ACTD dossiers for regulatory submissions.
- Coordinate with Manufacturing and R&D teams to collect required data and documents.
- Liaise with manufacturing sites to ensure ongoing regulatory compliance.
- Ensure timely execution of monthly regulatory submission plans and respond to regulatory queries within deadlines.
- Conduct gap analyses and update master regulatory data accordingly.
- Review key regulatory documents including Change Controls, Stability Protocols, Clinical Trial Protocols, and Packaging Artworks.
- Obtain country-specific feedback for variations and ensure timely submissions.
- Handle dossier renewals and update master data records.
- Conduct regular follow-ups with manufacturing teams for documentation and hold periodic review meetings.
- 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**: 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

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