
Regulatory Affairs _ US Market
4 weeks 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 _ US Market
1 week ago
Hyderabad, Telangana, India BVR People Consulting Full time ₹ 9,00,000 - ₹ 12,00,000 per yearGreetingsWe 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...
-
Regulatory Affairs
4 weeks ago
Hyderabad, India Clininfotech Full timeWe are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profile B.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...
-
Regulatory Affairs
2 weeks ago
Hyderabad, India LEE PHARMA LTD Full timeManaging regulatory affairs of the organization its subsidiaries/associates Liaising with regulatory bodies like State and Central FDA,DCI Well conversant with Drug law/feed supplement regulation Co-ordination with purchase, marketing departments Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW). **Salary**: From ₹171,172.50...
-
Executive Regulatory Affairs
4 days 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
1 week 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 Specialist
2 weeks ago
Hyderabad, India Weekday (YC W21) Full timeJob Description This role is for one of our clients Industry: Administrative and Support Services Seniority level: Mid-Senior level Min Experience: 3 years Location: India, Hyderabad JobType: full-time We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team. This role will be responsible for preparing, compiling,...
-
Senior Regulatory Affairs Specialist
16 hours ago
Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...
-
Regulatory Affairs IT Architect
4 days ago
Hyderabad, India beBeeTechnical Full timeSenior Technical Solution Specialist Create innovative IT solutions and services to meet quality and performance requirements and technical constraints. About the Role This position requires a consultant and advisor to improve complex global business processes, products, and services in Regulatory Affairs. Lead technical activities for transformative...
-
Regulatory Affairs- EU Market
2 weeks 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, Associate
7 days ago
Hyderabad, India Cellix Bio Full timeHere, everyone matters and you will be a vital contributor to our inspiring, bold mission. You will help make an impact on people’s lives and change futures every day. We are equally committed to bringing out your best and fostering a collaborative workplace built on trust and respect. We empower our people to take charge of their potential. We offer...