Exe (Regulatory Affairs) professional

Sun Pharma; Vadodara; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sun Pharma in Baroda seeks an experienced Regulatory and Business Continuity professional to manage product registrations and lifecycle activities across multiple health authorities.

You will oversee data review, dossier compilation, deficiency responses, eCTD submission, and cross-functional regulatory support, with 4–8 years of relevant experience and an M. Pharm.

This role offers a dynamic environment with growth opportunities within the R&D1 Regulatory Affairs unit.

Qualifications

• Regulatory affairs knowledge relevant to drug registrations.
• Experience with regulatory submissions to health authorities.
• Experience in post-approval changes and lifecycle management.

Responsibilities

• Review data and documents for product registrations.
• Prepare registration dossiers for FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters.
• Maintain life-cycle / post approval changes for drug product registration dossiers.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to health authorities.
• eCTD compilation, verification and submission through electronic gateway.
• Review and submission of annual reports to US FDA.
• Review and submission of post approval supplements to US FDA.
• Review plant change control and establish variation strategy for submission.
• Review of query responses prepared by regulatory associates.
• Review documents received from stakeholders for dossier compilation, query response and life cycle management.
• Allocation of projects to regulatory associates & manage the team for regulatory submissions.

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).