Manager 2 - Regulatory & Business Continuity

2 days ago

Tandalja, India SUN PHARMA Full time

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 1. New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside R&D) to ensure that sufficient and timely regulatory information and controls are included during design and development of drug products as per country specific regulatory requirements a. Provide feedback in terms of document requirements & regulatory filing strategy during development of new DF (Drug Formulation). Review and approve documents on behalf of regulatory. b. Preparation/review and submission of good quality dossiers thereby enabling faster approvals and timely launch c. Preparation and submission of meeting packages/scientific discussion with Agency related to product development d. Anticipate expected deficiencies and prepare mitigation plans 2. Approval: Prepare and submit timely response to deficiencies enabling approval of products. 3. Lifecycle Management for approved drug products a. Timely preparation and submission of annual reports/renewals b. Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies c. Regulatory Compliance - Ensure timely implementation of regulatory decisions for change management and other activities in DF plants d. Ensure reposition of comprehensive product information into central repository 4. Self and People Development a. Awareness of regulatory guidelines, participating and delivering presentations b. Provide on job training to Research Associates Travel Estimate 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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