Regulatory Affairs Jobs

Company: Novo Nordisk Global Business Services (GBS) Shape global regulatory strategies that bring innovative therapies to patients worldwide. If you thrive on complexity, enjoy building bridges acros

Key Responsibilities 1. Dossier Preparation & Submissions Prepare, review, and submit CTD / ACTD / country‑specific dossiers for: New product registrations Line extensions (strength, pack size, shelf

Job Summary: The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance

Job Description Build Our Future Together At Regeneron, we believe that the right idea, combined with the right team, can transform lives. Our global teams are dedicated to discovering, developing, an

Job Title: Senior Executive-Regulatory and Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G11B Location : Dadra At Sun Pharma, we commit to helping you “ Create your own sunshine

The Manager will serve as the on-the-ground leader of the Invoice to Settle (I2S) operational team based in Amgen India (Hyderabad), with operational accountability for a four-person team spanning thr

Job Title: Manager II – India Regulatory and business Conitnuity Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more tha

Senior Regulatory Affairs Associate 5+ years experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) i

Job Title: Regulatory and Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G12A Executive Location : Baroda At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by

Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted a

Description: Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practice

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.

Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-

Job Responsibility: Regulatory Affairs Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilizati

About the Role Seeking an experienced Regulatory Affairs Professional to lead / manage regulatory compliance activities for our Medical Device and In-Vitro Diagnostic (IVD) manufacturing operations. T