Senior Executive - FRD Non Orals

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.”

Job Description

• 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).