Manager - Regulatory Affairs
Sun Pharmaceutical Industries · Vadodara · onsite · Posted today
Undisclosed10–15 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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, 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
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).
This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Regulatory AffairsEctdclassificationProduct DevelopmentPharma
About Sun Pharmaceutical Industries
Sun Pharmaceutical Industries
Pharma
19.5k+
employees
1983
43 years old
Mumbai
India
₹7.1L PA avg
Avg at Sun Pharmaceutical Industries
About
Sun Pharma is committed to conducting its business by adopting the highest standards of professional integrity and ethical behavior.
Industries
PharmaHealthcare / PharmaManufacturingAnalytics & KPO
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