Exe (Regulatory Affairs)

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 400,000 - 680,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Baroda is seeking a Regulatory and Business Continuity professional to oversee regulatory submissions and lifecycle management for global health authorities. The role focuses on preparing dossiers, coordinating with R&D and QA teams, and ensuring timely responses to queries.

You will lead cross-functional submission activities, coordinate with FDA, EU, and other agencies, and support risk assessments and continuity planning.

Qualifications

• Educational background in regulatory affairs or related pharma field.
• Experience with regulatory submissions and cross-functional collaboration.
• Understanding of global regulatory processes is preferred.

Responsibilities

• Review data and documents for product registrations to health authorities.
• Compile registration dossiers for submission to US FDA, Health Canada, EU, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters from agencies.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to various health authorities.
• eCTD compilation, verification and submission through electronic gateway
• Review, preparation and submission of annual reports to US FDA
• Review, preparation and submission of post approval supplements to US FDA
• Reviewing plant change control and establish variation strategy for submissions
• Review of query responses and lifecycle management documents
• Allocation of projects to regulatory associates & manage the team for all regulatory submission activities

Education

M. Pharm

Tools

eCTD submission

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Regulatory and Business Continuity

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G12A Executive

Location :

Baroda

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Description

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters received from various agencies.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to various health authorities.
• eCTD compilation, verification and submission through electronic gateway
• Review, preparation and submission of annual reports to US FDA
• Review, preparation and submission of post approval supplements to US FDA
• Reviewing of the plant change control and established the variation strategy for submission
• Review of query response prepared and compiled by regulatory associates
• Review of all the documents received from stake holder fordossier compilation, Query response and Life cycle management
• Allocation of projects to regulatory associate & manage the team for all theregulatory submission activities

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).