Senior Executive - RA

Sun Pharmaceutical Industries, Inc.; Madhya Pradesh; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking a Regulatory and Business Continuity Senior Executive in Baroda. The role sits in the R&D1 Regulatory Affairs unit and focuses on end-to-end regulatory submissions for multiple health authorities and handling deficiency responses.

You will review data, compile dossiers for US FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel, and support cross-functional teams to ensure timely approvals. The position demands M.

Qualifications

• M. Pharm required.
• Strong knowledge of regulatory submissions and lifecycle for health authorities.
• Ability to prepare responses to deficiency letters and support cross-functional teams.

Responsibilities

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to US FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters from various agencies.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to 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.

Skills

Regulatory affairs

Education

M. Pharm

Job description

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Regulatory and Business Continuity

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11B Senior 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

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).