Exe (Regulatory Affairs)

Sun BioPharma, Inc.; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharma in Baroda, Gujarat seeks a Regulatory Affairs professional to manage product registrations and lifecycle activities. You will compile dossiers for major health authorities, respond to deficiency letters, and support cross-functional teams to ensure compliant submissions.

The role requires a Pharm degree and 4–8 years of regulatory experience, with exposure to US FDA, HC, and international dossiers. Growth and collaboration are emphasized in a supportive environment.

Qualifications

• M. Pharm degree required.
• 4–8 years of regulatory affairs experience.
• Experience with US FDA, Health Canada, EU/UK regulatory submissions.

Responsibilities

• Review data and documents for product registrations with health authorities.
• Compile registration dossiers for submission to US FDA, Health Canada, Europe, Australia, NZ, Japan and Israel.
• Prepare responses to deficiency letters from agencies.
• Maintain life-cycle / post-approval changes for drug dossiers.
• Provide regulatory support to cross-functional teams.
• Prepare and submit scientific advice to health authorities.
• eCTD compilation, verification and submission via electronic gateway.
• Review and submit annual reports to US FDA.

Skills

Regulatory affairs

Dossier preparation

Cross-functional collaboration

Education

M. Pharm

Job description

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.
• Maintain life-cycle / post approval changes for drug product registration dossiers.
• 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 for dossier compilation, Query response and Life cycle management
• Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure : 4 – 8 Yrs.

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).