Manager - Regulatory Affairs

SUN PHARMA; Madhya Pradesh; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Sun Pharma invites applications for Manager – Regulatory & Business Continuity in Vadodara. You will lead regulatory activities for US, EU and Canada markets, manage complex generics and drug-device combinations, and develop regulatory strategies.

The role requires M.Pharm and 10–15 years of relevant experience, with responsibility to prepare eCTD submissions and interact with agencies. Aims to ensure compliance and business continuity across regulatory programs.

Qualifications

• M.Pharm with regulatory affairs specialization.
• 10–15 years of relevant experience in regulatory affairs.
• Experience with US/EU/Canada regulatory submissions is preferred.

Responsibilities

• Lead regulatory activities for US, EU, and Canada markets.
• Handle Complex Generic Products and Drug-Device-Combination Products.
• Manage New ANDA submissions and agency query responses.
• Develop regulatory strategies for complex generic product development.
• Prepare and manage Controlled Correspondence, Pre-ANDA Meetings, Post-CR Meetings, and Scientific Advice interactions.
• Support product development teams from a regulatory perspective.
• Prepare and review eCTD submissions.

Skills

Regulatory affairs

Education

M.Pharm

Job description

Job Description

Job Title: Manager – Regulatory & Business Continuity

Business Unit: R&D1 Regulatory Affairs

Job Grade: G10

Location: Vadodara

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.”

Key Responsibilities

• Lead regulatory activities for US,EU,andCanadamarkets
• Handle ComplexGenericProducts and Drug-DeviceCombinationProducts
• Manage NewANDAsubmissions and agency queryresponses
• Develop regulatory strategies for complex generic product development
• Prepare and manage ControlledCorrespondence, Pre-ANDAMeetings, Post-CRMeetings, and ScientificAdviceinteractions
• Support product development teams from a regulatory perspective
• Prepare and review eCTDsubmissions

Travel Estimate

NA

Job Requirements

Educational Qualification

M.Pharm

Experience

Minimum 10 to15 years of relevant 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).