Manager - Regulatory Affairs

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Vadodara seeks an experienced Manager – Regulatory & Business Continuity to lead regulatory activities for global markets and to align regulatory strategies with business continuity planning.

Educational req is M.Pharm with 10–15 years of regulatory experience in complex generics. The role emphasizes leadership, collaboration, and proactive regulatory planning across R&D and manufacturing teams.

Qualifications

• Regulatory leadership across US, EU and Canada markets.
• Experience with New ANDA submissions and agency responses.
• Develop regulatory strategies for complex generic products.

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 CDR/Pre-ANDA meetings, Post-CR meetings, andScientific Advice interactions.
• Support product development teams from a regulatory perspective.
• Prepare and review eCTD submissions.

Skills

Regulatory leadership

GxP compliance

Cross-functional collab

Education

M.Pharm

Job description

Select how often (in days) to receive an alert: Create Alert

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Manager – Regulatory & Business Continuity

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G10

Location:

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

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).