
Regulatory Affairs _ US Market
4 days ago
Greetings
We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.
Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.
Key Responsibilities:
- Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved and Tentative) submissions.
- Responsible for filing supplements: CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates.
- Planning, reviewing, and timely submission of assigned projects in compliance with FDA guidelines.
- Strong interpretation of FDA queries and drafting of high-quality responses.
- Review and preparation of CMC sections (Module 2 & 3).
- Evaluation and interpretation of post-approval changes; preparation of related dossiers.
- Review of BMRs, specifications (drug product, drug substance, excipients), stability protocols.
- Preparation of Annual Reports/PEPFAR updates.
- Ensure compliance with high safety, quality, and regulatory standards.
Desired Candidate Profile
- M. Pharmacy (Pharmaceutics / Regulatory Affairs) with 611 years of relevant experience.
- In-depth knowledge of USFDA regulatory requirements.
- Strong expertise in CMC, post-approval changes, and supplements (CBE, CBE-30, PAS).
- Excellent drafting, reviewing, and query interpretation skills.
- Exposure to ANDA/NDA lifecycle management.
Interested Candidates Kindly Share your updated cv to
-
Regulatory Affairs Associate
2 weeks ago
Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRegulatory Affairs AssociateExperience: 3-6 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval
-
Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Revio Therapeutics Full time ₹ 12,00,000 - ₹ 24,00,000 per yearRole DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...
-
Executive Regulatory Affairs
4 hours ago
Hyderabad, Telangana, India Jodas Expoim Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob Title: Regulatory Affairs ExecutiveDepartment: Regulatory AffairsLocation: HyderabadExperience: 1-5 YearsIndustry: Pharmaceuticals (Injectables / OSD)About Jodas ExpoimJodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation,...
-
Regulatory Affairs Manager
6 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
-
Regulatory Affairs- EU Market
1 week ago
Hyderabad, Telangana, India V3 Staffing Full time ₹ 9,00,000 - ₹ 12,00,000 per yearGreetings of the day Our reputed MNC Client is hiring for:Designation: Regulatory Affairs- EU Market- Pre & Post ApprovalLocation: HyderabadShift: GeneralWork Mode: WFO (5 days working)Interview Mode: F2F interviewNOTE: Looking for candidates from Generic Pharma and not from API as this is for formulationRole & responsibilities:Component with EU-Filing...
-
Regulatory Affairs Analyst
2 weeks ago
Hyderabad, Telangana, India Dr Reddys Laboratories Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRegulatory Affairs Analyst 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 collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait. We started in 1984...
-
Regulatory Affairs Specialist
1 week ago
Hyderabad, Telangana, India Medtronic Full time ₹ 5,00,000 - ₹ 12,00,000 per yearAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...
-
Regulatory Affairs- eCTD Specialist
2 weeks ago
Hyderabad, Telangana, India Nooha Asp Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRegulatory Affairs Hiring Profile eCTD SpecialistExperience Level: 3 to 6 YearsLocation: Work from office (Hyderabad)Skills & Qualifications:1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the...
-
Regulatory Affairs Manager
1 week ago
Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearRegulatory Affairs Manager (CMC) Career CategoryInformation Systems Job Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of...
-
Regulatory Affairs Manager
6 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRegulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA...