Manager, Regulatory Affairs
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
Senior Regulatory Affairs Specialist
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
Exe (Regulatory Affairs)
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
Deputy Manager, Regulatory Affairs
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
Assistant Manager, Regulatory Affairs
Description: Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practice
Executive, Regulatory Affairs
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.
Assistant Manager, Regulatory Affairs
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-
Senior Executive, Regulatory Affairs
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
Regulatory Affairs Professional
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
Specialist Regulatory Affairs - NBE
Company Description Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one col
Regulatory Affairs Specialist
Ensure compliance with regulatory requirements for drug approvals and submissions. Category: Regulatory Mode: Hybrid Responsibilities: Prepare regulatory submissions Liaise with authorities Track regu
ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver
Senior Manager, Regulatory Affairs (Biologics)
Title: Senior Manager, Regulatory Affairs (Biologics) Job Grade: G9 Work Setting: Hybrid (2-3 Days onsite per week) Location: Gurgaon (preferable)/Baroda/Mumbai At Sun Pharma, we commit to helping you
Senior Executive, Regulatory Affairs
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 Description Summary The Packaging Regulation, Sustainability & PPWR Program Leader is a senior individual contributor within GE HealthCare’s global Packaging Engineering function, responsible for
This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to en
Senior Manager-Regulatory Submission Management
Accountability: * Provide leadership and direction for the Submission Management sub-team within Submission Management. *Accountable for performance and results of Submission Management sub-team team
Architect – Product Safety & Regulatory Engineering
Job Description Summary Lead Product Safety, Regulatory Compliance, Risk Management, and Design Controls for GE HealthCare's X-Ray Tube and X-Ray Generator portfolio across the entire product lifecycl