Manager 2 - Regulatory & Business Continuity
Manager 2 - Regulatory & Business Continuity
SUN PHARMAThis job is no longer accepting applications
Job Description
Job Title
Manager – Regulatory & Business Continuity
Business Unit
R&D1 Regulatory Affairs
Job Grade
G11A
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 Summary
Job Description
during design and development of drug products as per country specific regulatory requirements
NA
Job Requirements
Educational Qualification
Graduate : M.Pharm
Experience
Tenure : 8-10 years
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
G11A
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 Summary
Job Description
- New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside
during design and development of drug products as per country specific regulatory requirements
- Provide feedback in terms of document requirements & regulatory filing strategy during development
- Preparation/review and submission of good quality dossiers thereby enabling faster approvals and
- Preparation and submission of meeting packages/scientific discussion with Agency related to product
- Anticipate expected deficiencies and prepare mitigation plans
- Approval: Prepare and submit timely response to deficiencies enabling approval of products.
- Lifecycle Management for approved drug products
- Timely preparation and submission of annual reports/renewals
- Evaluation, preparation and submission of changes through variations, supplements etc that impact
- Regulatory Compliance - Ensure timely implementation of regulatory decisions for change
- Ensure reposition of comprehensive product information into central repository
- Self and People Development
- Awareness of regulatory guidelines, participating and delivering presentations
- Provide on job training to Research Associates
NA
Job Requirements
Educational Qualification
Graduate : M.Pharm
Experience
Tenure : 8-10 years
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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