Executive - RA EM

3 days ago

Tandalja, India SUN PHARMA Full time

Job Title: Executive – Regulatory & Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G12A 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 Description: Preparation of registration strategy for Brazil submission Adequate understanding on respective authority guidance and filing of new product and post approval changes Review of documents related to product registration and dossier submission leading to faster approval Prepare response to deficiency letter received from Anvisa, Brazil Maintain life-cycle (PCH) / post approval changes for drug product registration dossiers including timely circulation of approval information Provide regulatory support to cross functional department Adequate assessment of change control as per regulatory guidance Prepare and submit scientific advice to Anvisa, Brazil Travel Estimate NA Job Requirements Educational Qualificatio Graduate : M.Pharm Experience Tenure : 1-2 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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