Executive - Regulatory Affairs (Emerging Markets)

Why This Role Matters
The Executive – Regulatory Affairs (Emerging Markets) is responsible for ensuring timely approvals of pharmaceutical products in the MENA and African regions by preparing high-quality regulatory dossiers. The role plays a key part in lifecycle management, regulatory compliance, and submission of new products, renewals, and variations. By supporting cross-functional teams and maintaining accurate regulatory documentation, this position ensures products meet local regulatory requirements while enabling smooth market entry and ongoing compliance.

Job Description
The Executive – Regulatory Affairs (Emerging Markets) manages regulatory submissions, lifecycle management, and compliance activities for MENA markets, South Africa, and GCC countries. The role involves preparing, reviewing, and submitting CMC dossiers, responding to regulatory queries, managing variations, and ensuring proper documentation for approvals. The position supports timely regulatory approvals through detailed review, coordination with stakeholders, and alignment with local requirements.

Key Features of the Role
Regulatory submission of new products, renewals, and variations.
Lifecycle management of drug formulations for MENA, South Africa, and GCC markets.
Preparation of high-quality CMC dossiers and approval packages.
Collaboration with cross-functional teams including manufacturing, R&D, and quality.
Ensure compliance with country-specific regulations and maintain regulatory documentation.
Position based in Baroda within Sun Pharmaceutical Industries Ltd.

Responsibilities
Prepare and review CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions and renewals.
Review development reports, scale-up reports, specifications, stability protocols, artworks, and related documents before initiation of exhibit batches.
Prepare responses to deficiencies to enable approval of products filed with regulatory agencies.
Prepare and review variations to support changes such as API vendor changes, ROS/test parameter updates, drug formulation site changes, and product harmonization.
Ensure regulatory compliance by preparing and circulating approval packages with product history sheets to stakeholders.
Update central repositories with comprehensive product information.
Review the regulatory impact of variations, change controls, and other product updates.

Required Qualifications
Knowledge of regulatory requirements and submission processes for emerging markets (MENA, South Africa, GCC).
Understanding of CMC dossiers, variations, and lifecycle management.
Strong analytical, documentation, and coordination skills.
Ability to collaborate effectively with cross-functional teams and stakeholders.

Educational Requirements
M.Sc or M.Pharm.

Experience and Skills
1–4 years of relevant experience in regulatory affairs.
Hands-on experience preparing and reviewing CMC dossiers, product variations, and submissions.
Knowledge of emerging market regulatory guidelines and compliance requirements.
Ability to manage lifecycle management activities and coordinate with multiple teams.

Salary Insights
Competitive salary based on experience, qualifications, and organizational role.

Company Overview
Sun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company based in India, recognized for specialty generics and innovative medicines. Operating in over 100 countries, Sun Pharma focuses on delivering high-quality, safe, and affordable treatments. The company encourages a culture of growth, collaboration, and continuous improvement.

FAQs
Who can apply for this role?
Candidates with 1–4 years of experience in regulatory affairs, preferably in emerging markets.

Which markets will this role focus on?
MENA, South Africa, and GCC countries.

Is travel required?
Not applicable.

Is prior submission experience mandatory?
Yes, experience with CMC dossiers, variations, and regulatory approvals is preferred.

Application Tips
Highlight experience in regulatory submissions, CMC dossiers, and lifecycle management.
Include knowledge of emerging market regulations (MENA, South Africa, GCC).
Showcase collaboration with cross-functional teams and documentation skills.
Emphasize attention to detail, compliance understanding, and regulatory problem-solving abilities.