Senior Executive

5 days ago

Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

Job Title Senior Executive Manager 2 Formulation Development Non Orals Business Unit R D1 Regulatory Affairs Job Grade G11B 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 Experience in end-to-end topical product parenteral product injection product development activities for generic product development ANDA Cream ointment gel solution lotion foam patch solution injection depo injection prefilled syringe cartridge based injection etc as well as NDA 505 b 2 and 505 b 1 Experience in execution of lab scale manufacturing reverse engineering analytical know-how plant level manufacturing activities scale-up and exhibit batches based on quality principles QbD QTPP CQA CMA CPP RA FMEA Experienced scientist to perform experiments for development of optimum prototypes generic non-infringing composition and robust manufacturing process with diverse class of drugs prodrugs sensitive to pH acid base temperature oxygen humidity Experience in regulatory documentation CMC MF BMR PDR controlled correspondence for CMC Biowaiver Dossier preparation for US-FDA EU-EMA AU-TGA DCGI through successful filing Experience in working with cross-functional teams ADD MSTG production QC QA RA IPC PMO BD Microbiology Pharmacology etc to achieve project goals - Filings and subsequent approvals Knowledge and develop continuous understanding on competitive intelligence due diligence US-FDA quality concepts statistics and global pharma trend analysis to support new product evaluation introduction Travel Estimate NA Job Requirements Educational Qualification M Pharm or PhD Experience Tenure 6 to 8 years if M harm or 3 5 years if PhD 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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