Regulatory Affairs Associate – Endo | Job in Digha | Apply by 30 April 2025
Are you ready to be the change in the healthcare industry? Endo, a global pharmaceutical company with a mission to develop life-enhancing products, is hiring a Regulatory Affairs Associate at its Digha, India location. With over 3,000 team members globally, Endo is known for its inclusive, collaborative, and innovation-driven work culture. If you are passionate about compliance, documentation, and regulatory submissions, this role is for you!
About Endo International plc
Endo International plc is a specialty pharmaceutical company committed to improving patients’ lives through the development and delivery of high-quality, life-enhancing medications. With a legacy of innovation and a presence in more than 60 countries, Endo focuses on branded and generic pharmaceuticals in areas such as pain management, urology, endocrinology, and orthopedics. At Endo, over 3,000 employees globally are united by a shared mission—to develop products that make a meaningful difference in healthcare. Through scientific excellence, strategic partnerships, and a strong sense of purpose, Endo continues to address unmet medical needs while maintaining the highest standards of quality and compliance. Endo is not just a place to work—it’s a place to grow, contribute, and be
part of something impactful.- Job Role: Associate – Regulatory Affairs
- Locations: India – Digha
- Time Type: Full-time
- Time Left to Apply: April 30, 2025
- Job Requisition ID: R002329
Job Description Summary
Regulatory Affairs Associate is responsible for the timely preparation and submission of adequate and accurate ANDAs and supplements in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. Also can responsible for oral solids (tablets, capsules) or sterile liquids dosage forms for the R&D pipeline, as well as marketed products. Evaluates the quality and content of dossiers to ensure fast product.
Job Description
- Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements.
- Prepare and review the ANDA’s sections.
- Compile controlled correspondences for excipients, Q1/Q2 queries, BE guidance and general queries to FDA.
- Assist in the development of regulatory strategies & implementation in an effort to manage complex issues that may have a significant impact on the Company’s internal and external product portfolio and product approval process.
- Knowledge sharing sessions to be conducted as and when needed
Qualification: M.Pharm
Experience: 1 year CMC in injectable formulation
Keywords: Regulatory affairs job India, Endo careers Digha, M.Pharm jobs 2025, CMC regulatory associate, Injectable formulation career, ANDA submission jobs, Regulatory pharma jobs India
