Manager - Regulatory Affairs
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
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).
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
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).
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