Position: Assistant Manager – Regulatory Affairs
Department: Regulatory Affairs
Location: Pune, India
Experience: 7–10 Years
Qualification: B. Pharm / M. Pharm
Work Type: Full-time / On-site
Reporting To: Manager / Head – Regulatory Affairs
Preferred: Male/ Female candidate
About the Role
We are seeking a proactive, detail-oriented Assistant Manager – Regulatory Affairs with strong experience in Middle East & North Africa (MENA), Africa & LATAM markets. The role involves regulatory submissions, dossier preparation, lifecycle management, and ensuring compliance for global registration across ROW markets, leading to timely product approvals.
Key Responsibilities
1. Regulatory Strategy, Dossier Preparation & Submissions
- Lead and manage preparation, review, and submission of eCTD/CTD/ACTD dossiers for product registrations, renewals, and variations across MENA, Africa & LATAM regions.
- Develop and implement market-specific regulatory strategies aligned with business objectives.
- Ensure dossiers meet country-specific formatting including Module 1 (Administrative/Country Specific requirements).
- Coordinate with internal teams to ensure timely, accurate submissions and handle deficiency letters/queries from regulatory agencies.
2. Regulatory Compliance, Documentation & Record Management
- Review technical documentation, CMC data, analytical methods, and stability reports for compliance.
- Collaborate with R&D, QA, QC, Production, Marketing, BD, and Sourcing to gather and validate submission data.
- Maintain regulatory trackers, submission logs, and correspondence databases.
- Support audits, ensuring systems and documentation are audit-ready and compliant.
3. Labeling, Artwork & Post-Approval Compliance
- Review and approve packaging, labeling, and promotional materials for compliance in MENA, Africa & LATAM markets.
- Coordinate with artwork and marketing teams to incorporate approved regulatory text.
- Manage post-approval changes, renewals, and labeling updates.
4. Regulatory Intelligence & Market Monitoring
- Monitor and interpret regulatory updates for ROW markets, especially MENA, Africa & LATAM regions.
- Communicate market changes, new guidelines, and strategic implications to stakeholders.
- Implement regulatory updates across templates, documentation, and submission procedures.
5. Communication, Stakeholder Management & Leadership Support
- Act as a regulatory point of contact with authorities, partners, and distributors.
- Provide reports and submission status updates to senior management.
- Mentor junior regulatory professionals on documentation and submission best practices.
- Ensure adherence to global regulatory and quality compliance standards.
Skills & Competencies
- Strong knowledge of CTD / eCTD / ACTD formats, lifecycle management, renewals & variations.
- Proven experience in regulatory submissions for MENA, Africa & LATAM markets.
- Excellent communication, coordination, documentation, and analytical abilities.
- Proficient in regulatory databases, submission trackers, and project management tools.
- Ability to meet deadlines and mentor junior team members.
Pay: ₹650,000.00 - ₹950,000.00 per year
Benefits:
Work Location: In person
