
Regulatory Affairs Officer
5 days ago
This role is for one of the Weekday's clients
Salary range: Rs Rs ie INR LPA)
Min Experience: 3 years
Location: Hyderabad
JobType: full-time
We are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, and licensing processes, particularly within the botanical and herbal healthcare domain. This role is responsible for ensuring regulatory compliance, driving product registrations, and maintaining approvals across domestic and international markets.
Requirements
Key Responsibilities:
- Prepare, compile, and submit Drug Master Files (DMF) and other regulatory dossiers for botanical and herbal healthcare products.
- Ensure compliance with ICH guidelines and Indian regulatory requirements, including CDSCO norms.
- Manage licensing, registrations, renewals, and variations with regulatory bodies.
- Serve as the primary point of contact between regulatory authorities and internal departments to resolve queries effectively.
- Monitor regulatory updates and implement necessary changes to maintain compliance.
- Provide regulatory guidance to R&D and quality assurance teams during product development and manufacturing.
- Maintain accurate regulatory documentation and track submission timelines.
- Support regulatory inspections and audits.
- Develop and execute regulatory strategies tailored to botanical and herbal healthcare products for different markets.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, or a related field (advanced degrees preferred).
- 2–8 years of experience in regulatory affairs, ideally within botanical or herbal healthcare.
- Demonstrated experience in DMF preparation and submission.
- Strong knowledge of ICH guidelines (Q7, Q9, Q10, Q11) and Indian regulatory framework (CDSCO).
- Proven track record in managing licensing and registration processes for healthcare products.
- Excellent communication and documentation skills.
- Strong organizational and collaborative working abilities.
Preferred:
- Experience with regulatory submissions to global agencies such as US FDA, EMA, etc.
- Familiarity with GMP requirements for botanical/herbal products.
- Understanding of safety and efficacy documentation for herbal healthcare.
-
Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Thepharmadaily Full timeJob Description- Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations- Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met- Provide regulatory support for research and development activities and ensure compliance with Indian and...
-
Regulatory Affairs Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time US$ 1,54,000 - US$ 2,41,300Regulatory Affairs ExpertThe Regulatory Affairs Manager is responsible for leading the execution and coordination of global regulatory activities.Key Responsibilities:Develop and execute strategic plans for global and country-specific regulatory complianceProvide CMC regulatory strategy by defining filing requirements, submission strategies, and risk...
-
Senior Regulatory Affairs Professional
2 days ago
Hyderabad, Telangana, India beBeeregulatory Full time ₹ 18,00,000 - ₹ 24,00,000Regulatory Affairs Senior AssociateWe are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.Preparation, tracking, reporting, and archiving US regulatory documentationManagement of Ad Promo...
-
Regulatory Affairs Officer
3 weeks ago
Hyderabad, Telangana, India Weekday AI Full timeThis role is for one of the Weekday's clientsSalary range: Rs 300000 - Rs 800000 (ie INR 3-8 LPA)Min Experience: 3 yearsLocation: India, HyderabadJobType: full-timeRequirementsKey Responsibilities:Drug Master Files (DMF):- Prepare, compile, and review US DMFs (Type II), EU ASMFs, and other region-specific dossiers.- Manage lifecycle activities such as...
-
Regulatory Affairs Professional
1 day ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000About the roleWe are seeking a seasoned Regulatory Affairs professional to manage end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions.Manage cross-functional teams to collect required data and documentation for timely regulatory submissions.Compile CMC documentation in compliance with FDA...
-
Regulatory Affairs Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Senior Regulatory Specialist Job DescriptionThis role involves leading the preparation and submission of FDA 510(k) premarket notifications for medical devices. You will be responsible for preparing and reviewing regulatory documentation to ensure compliance with FDA regulations and standards.Key Responsibilities:Develop strategic plans for regulatory...
-
Regulatory Affairs Coordinator
4 days ago
Hyderabad, Telangana, India beBeeAdministrative Full time ₹ 51,00,000 - ₹ 79,00,000This role supports the Regulatory Translation Hub by managing access to repository folders, maintaining software licenses and updating team lists.Key ResponsibilitiesCoordinates general administrative tasks for the Regulatory Translation Hub.Manages access to relevant repositories, maintains records and ensures software renewal.Organizes documentation,...
-
Hyderabad, Telangana, India Seven Consultancy Full timeJOB DETAILS 1) Generation of New Artwork in Co-ordination of Artist & Record Keeping of the same2) Revision of Existing Artworks& Communicating to Purchase, Plant, Production & Logistics3) Checking & Approval of Artworks from Buyer & Vendor and Tracking of the same4) Follow-up with Buyers & Vendors for timely approval of Artworks5) Verification of Bill of...
-
Senior Regulatory Affairs Specialist
6 days ago
Hyderabad, Telangana, India beBeeRegulatory Full timeJob Title: Senior Regulatory Affairs SpecialistOverviewKamet Consulting Group is a leading management consulting firm serving the life sciences industry. We are currently seeking an experienced Senior Regulatory Affairs Specialist to join our team.Key ResponsibilitiesMonitor and analyze regulatory changes, trends, and developments in the pharmaceutical and...
-
Regulatory Affairs CMC Manager
4 days ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...