Executive Regulatory Affairs

Why This Role Matters
The Executive Regulatory Affairs (US Group) plays a critical role in ensuring compliance with USFDA, ICH guidelines, and regional regulations (US, EU, India) while supporting the submission of regulatory dossiers for new drug applications, ANDAs, MAAs, and post-approval changes. By coordinating with cross-functional teams, maintaining regulatory databases, and responding to queries from authorities, this role ensures timely approvals and smooth regulatory operations. The position contributes directly to the company’s ability to launch products in key markets while maintaining high standards of regulatory compliance.

Job Description
The Executive Regulatory Affairs (US Group) is responsible for preparing, compiling, and submitting regulatory dossiers (CTD/eCTD) for new drug applications, ANDAs, MAAs, and post-approval changes. The role supports regulatory strategy development for new products and markets, ensures proper documentation and compliance, and coordinates with cross-functional teams including CDMO, R&D, and Manufacturing. The professional will also track submission timelines, maintain regulatory databases, and respond to queries or deficiency letters from regulatory authorities.

Key Features of the Role
Strong involvement in USFDA regulatory submissions and compliance.
Exposure to ICH guidelines and regional regulatory requirements (US, EU, India).
Preparation and submission of regulatory dossiers (CTD/eCTD).
Participation in regulatory strategy planning for new products and markets.
Collaboration with CDMO, R&D, Manufacturing, and other cross-functional teams.
Tracking submission timelines and managing regulatory databases.
Position within Sun Pharmaceutical Industries Ltd.

Responsibilities
Prepare, compile, and submit regulatory dossiers for NDAs, ANDAs, MAAs, and post-approval changes.
Support regulatory strategy development for new products and markets.
Coordinate with cross-functional teams to gather required documentation and data.
Respond to queries and deficiency letters from regulatory authorities.
Maintain regulatory databases and track submission timelines and approvals.
Ensure compliance with USFDA, ICH, and other regional regulations.
Provide regulatory guidance to project teams for successful submissions.

Required Qualifications
Strong knowledge of USFDA regulations, ICH guidelines, and regional regulatory requirements.
Experience with CTD/eCTD submission formats and regulatory dossiers.
Familiarity with regulatory databases and submission tracking systems.
Analytical and detail-oriented with strong documentation skills.
Ability to collaborate effectively with cross-functional teams and external partners.

Educational Requirements
Graduate degree in M.Pharm.

Experience and Skills
2–5 years of relevant experience in regulatory affairs, particularly with USFDA submissions.
Hands-on experience preparing and submitting regulatory dossiers.
Knowledge of ANDAs, NDAs, MAAs, and post-approval changes.
Strong understanding of regulatory strategy and compliance requirements.
Effective communication, documentation, and problem-solving skills.

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 experience in US regulatory submissions, ANDAs, NDAs, and regulatory affairs.

What submissions will this role handle?
CTD/eCTD dossiers for NDAs, ANDAs, MAAs, and post-approval changes.

Is travel required?
Not applicable.

Is prior US regulatory experience mandatory?
Yes, experience in USFDA submissions is preferred.

Application Tips
Highlight experience in regulatory submissions, especially USFDA and CTD/eCTD.
Include knowledge of ICH guidelines, ANDAs, NDAs, MAAs, and post-approval changes.
Demonstrate collaboration with cross-functional teams and strong documentation skills.
Emphasize analytical abilities, regulatory compliance understanding, and problem-solving skills.