Sun Pharma Hiring Regulatory Affairs Executive

Sun Pharmaceutical Industries Ltd; Bharuch District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. in Baroda, Gujarat seeks an Executive – Regulatory Affairs to lead global product registrations and dossier submissions in the R&D1 Regulatory Affairs function.

The role focuses on eCTD submissions, post-approval changes, and lifecycle management, with exposure to major health authorities including US FDA, Health Canada, Europe and Australia/New Zealand. The ideal candidate holds an M.Pharm and 4–8 years of regulatory experience, excels in cross-functional

Qualifications

• M.Pharm is the required educational qualification.
• 4–8 Years of experience in Regulatory Affairs.
• Experience in global regulatory submissions is suitable for this position.

Responsibilities

• Review data and documents related to product registrations for regulatory authorities.
• Compile registration dossiers for global submissions.
• Prepare responses to deficiency letters from regulatory agencies.
• Maintain lifecycle and post-approval changes for registrational dossiers.
• Provide regulatory support to cross-functional departments.
• Prepare and submit scientific advice to health authorities.
• Support submissions across assigned products and markets.

Skills

Regulatory Affairs

Global Regulatory Submissions

eCTD Compilation

Dossier Compilation

US FDA Submissions

Lifecycle Management

Query Response Management

Cross-Functional Coordination

Education

M.Pharm

M.Pharm Regulatory Affairs

Job description

Executive – Regulatory Affairs | Sun Pharma

Sun Pharmaceutical Industries Ltd. is hiring an Executive – Regulatory Affairs for its R&D1 Regulatory Affairs function in Baroda.
The position focuses on global product registrations, regulatory dossier compilation, eCTD submissions, post-approval changes, deficiency responses, and regulatory lifecycle management.
Candidates should have an M.Pharm qualification with 4–8 years of relevant Regulatory Affairs experience.
The role provides exposure to submissions for major health authorities, including the US FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.

Job Details

Position

Executive – Regulatory Affairs

Company

Sun Pharmaceutical Industries Ltd.

Job Title / Function

Regulatory and Business Continuity

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A Executive

Location

Baroda, Gujarat

Site

Tandalja – R&D

Experience

4–8 Years

Travel

NA

Regulatory Affairs Responsibilities

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to global health authorities.
• Prepare responses to deficiency letters received from regulatory agencies.
• Maintain lifecycle and post-approval changes for drug product registration dossiers.
• Provide regulatory support to cross-functional departments.
• Prepare and submit scientific advice to various health authorities.
• Support regulatory submission activities across assigned products and markets.

Global Regulatory Submissions

The role involves regulatory registration and submission activities for health authorities and markets including:

• US FDA
• Health Canada
• Europe
• Australia/New Zealand
• Japan
• Israel

eCTD & Dossier Management

• Perform eCTD compilation, verification, and submission through electronic gateways.
• Review documents received from stakeholders for dossier compilation.
• Review documents for query responses.
• Review documentation supporting lifecycle management activities.
• Ensure regulatory dossiers are prepared and maintained according to applicable requirements.

US FDA Regulatory Activities

• Review, prepare, and submit annual reports to the US FDA.
• Review, prepare, and submit post-approval supplements to the US FDA.
• Support post-approval regulatory activities for registered drug products.
• Maintain regulatory documentation throughout the product lifecycle.

Regulatory Query & Variation Management

• Prepare responses to deficiency letters received from regulatory agencies.
• Review query responses prepared and compiled by regulatory associates.
• Review plant change controls.
• Establish appropriate variation strategies for regulatory submissions.
• Coordinate with stakeholders to obtain documents required for dossier compilation and query responses.

Team & Cross-Functional Coordination

• Provide regulatory support to cross-functional departments.
• Allocate projects to regulatory associates.
• Manage the team for regulatory submission activities.
• Coordinate with stakeholders for dossier compilation, query responses, and lifecycle management.
• Ensure assigned regulatory activities are completed according to submission requirements.

Eligibility & Qualifications

Educational Qualification

• M.Pharm

Eligible Qualification Courses

M.Pharm Regulatory Affairs | M.Pharm Pharmaceutics | M.Pharm Pharmaceutical Analysis | M.Pharm Quality Assurance | Other Relevant M.Pharm Specializations

The official job posting specifies M.Pharm as the required educational qualification.

Experience

• 4–8 Years
• Relevant experience in Regulatory Affairs and global regulatory submissions is suitable for this position.

Key Regulatory Skills

• Regulatory Affairs
• Global Regulatory Submissions
• Regulatory Dossier Compilation
• eCTD Compilation
• Product Registration
• US FDA Submissions
• Health Canada Submissions
• European Regulatory Submissions
• Post-Approval Changes
• Lifecycle Management
• Annual Reports
• Post-Approval Supplements
• Deficiency Letter Responses
• Query Response Management
• Change Control Review
• Variation Strategy
• Regulatory Documentation
• Cross-Functional Coordination