Formulation Regulatory Affairs- Assistant General manager (ROW Market)

MSN Group; Hyderabad; Vor Ort; INR 4.000.000 - 6.000.000; Vollzeit

Zusammenfassung

MSN Laboratories Pvt. Ltd. is seeking an experienced Regulatory Affairs professional to lead regulatory activities for formulations across ROW markets.

The candidate will drive regulatory strategy, dossier management, product registrations and lifecycle compliance. The role requires 15–20 years of global regulatory experience, strong leadership, and the ability to manage complex submissions with cross-functional teams.

Qualifikationen

• Minimum 15–20 years of regulatory affairs experience in pharmaceutical formulations.
• Expertise in CTD/ACTD dossier preparation and submissions for ROW markets.
• Strong leadership and stakeholder management skills with ability to mentor teams.

Aufgaben

• Lead regulatory submissions and product registrations across ROW markets.
• Manage dossier preparation, review, and submission (CTD/ACTD) for global markets.
• Oversee lifecycle management including renewals, variations and post-approval changes.
• Coordinate with international regulators, agents, and cross-functional teams.

Kenntnisse

ROW regulatory affairs

CTD/ACTD submissions

Regulatory strategy

Lifecycle management

Leadership

Stakeholder management

Team mentoring

Ausbildung

M.Pharm

Jobbeschreibung

Role & responsibilities

Company: MSN Laboratories Pvt. Ltd.
Designation: Assistant General Manager (AGM) Regulatory Affairs
Department: Regulatory Affairs Formulations (ROW)
Experience: 15–20Years
Qualification: M.Pharm
Industry: Pharmaceutical / Formulations
Job Location: As per company requirement

Job Summary

MSN Laboratories is looking for an experienced Regulatory Affairs professional to lead and manage regulatory activities for pharmaceutical formulation products across ROW (Rest of the World) markets. The candidate will be responsible for regulatory strategy, dossier management, product registrations, lifecycle management and ensuring compliance with international regulatory requirements.

Key Responsibilities

1. Lead regulatory submissions and product registration activities across ROW markets, including Africa, ASEAN, CIS, LATAM and Middle East.
2. Manage preparation, compilation, review and submission of CTD, ACTD and country-specific regulatory dossiers.
3. Handle new product registrations, renewals, variations and post-approval changes.
4. Review technical documents related to formulation development, analytical development, stability studies, process validation, specifications and manufacturing processes.
5. Manage regulatory queries, deficiency letters and responses from international regulatory authorities.
6. Coordinate with overseas agents, consultants, distributors and internal stakeholders for regulatory approvals.
7. Develop regulatory strategies based on country-specific guidelines and business requirements.
8. Monitor regulatory updates and ensure compliance with ICH, WHO-GMP and applicable country-specific guidelines.
9. Drive regulatory lifecycle management and maintain product registration databases.
10. Lead and mentor the Regulatory Affairs team and ensure timely completion of regulatory deliverables.
11. Coordinate with Formulation R&D, Analytical R&D, QA, QC, Production, Packaging and International Business teams.

Required Skills

• Strong knowledge of ROW regulatory affairs and international product registrations.
• Expertise in CTD / ACTD dossier preparation and review.
• Experience in pharmaceutical formulation regulatory submissions.
• Knowledge of country-specific regulatory requirements.
• Expertise in product registration, renewals, variations and lifecycle management.
• Experience in regulatory query handling and deficiency responses.
• Good leadership, communication and stakeholder management skills.

Educational Qualification

M.Pharm in Pharmaceutics, Pharmaceutical Chemistry or a relevant pharmaceutical discipline.

Experience

15–20 years of relevant experience in Pharmaceutical Regulatory Affairs, with significant exposure to ROW market formulation registrations and team management.

Preferred Candidate Profile

Candidates currently working in Pharmaceutical Formulation Regulatory Affairs with strong ROW market exposure and experience managing international regulatory submissions will be preferred.