
Regulatory Affairs
1 day ago
Area Of Responsibility
To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.
To review outsourced intermediates and APIs for regulatory adequacy to support Procurement Team in vendor selection and DF-Regulatory for ANDA/MA submission.
To coordinate & support Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies for regulatory submissions as well as for responding regulatory queries.
To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.
Deliverables
Compilation and review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updation.
Preparation and review of Regulatory Amendments / Variations for smooth API supplies
Preparation of responses to regulatory deficiencies
Regulatory support to Chemical Research Department, Analytical Department, Chemical manufacturing, Quality Assurance, Procurement Team and Regulatory Affairs-Pharma
Ensure reposition of regulatory database and compliance to departmental guidelines.
-
Regulatory Affairs Lead
5 days ago
Gurgaon, Haryana, India beBeeRegulatoryAffairsManager Full time ₹ 1,04,000 - ₹ 1,30,878Job Title: Senior Regulatory Affairs ManagerThe role of the Senior Regulatory Affairs Manager is to serve as a high-level expert in regulatory affairs, overseeing the development and implementation of regulatory strategies for products. This includes interacting with regulatory agencies to expedite approval, serving as a liaison throughout the product...
-
Regulatory Affairs Expert
2 days ago
Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 18,00,000 - ₹ 24,00,000Job DescriptionWe are seeking an experienced Regulatory Affairs expert to lead product registration submissions and reports. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage complex projects.Key ResponsibilitiesLiaise with regulatory agencies for approval and compliance.Provide regulatory guidance during product...
-
Regulatory Affairs Coordinator
7 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000Regulatory Affairs CoordinatorJob Summary:As a Regulatory Affairs Coordinator, you will be responsible for developing and implementing processes to ensure compliance with regulatory requirements at the district and state level.This includes tracking and establishing procedures for PC&PNDT regulations and AERB regulations for medical devices.You will work...
-
Regulatory Affairs Specialist
2 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 22,50,000Regulatory Affairs SpecialistAbout the Role:We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring that our products comply with relevant regulations and guidelines.Key Responsibilities:Support the product lifecycle through obsolescence by assessing changes made to...
-
Regulatory Affairs Specialist
6 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 50,00,000 - ₹ 75,00,000Regulatory Affairs PositionWe are seeking a highly motivated individual to fill the role of Regulatory Affairs Specialist. The ideal candidate will be responsible for tracking and establishing processes related to PC& PNDT and AERB regulations at the District / State level.Key Responsibilities:Process Tracking and Establishment: Track and establish process...
-
Expert Regulatory Affairs Leader
6 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000Senior Regulatory Affairs Manager RoleThis is a key leadership position that requires strong expertise in Regulatory Affairs.Job Responsibilities:Lead the development of product registration submissions, progress reports, and periodic experience reports.Engage with regulatory agencies to expedite approval of pending registrations and ensure compliance with...
-
Project Manager – Regulatory Affairs
4 days ago
Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time US$ 90,000 - US$ 1,20,000 per yearJob SummaryWe are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global...
-
Regulatory Affairs Specialist
7 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878Job Title: Regulatory Affairs SpecialistWe are seeking a detail-oriented and organized professional to assist with the preparation and submission of crucial regulatory documents. This role primarily focuses on Module 1 documents and various lifecycle maintenance activities, ensuring compliance with global regulations.The ideal candidate will have a master's...
-
Assistant Manager- Regulatory affairs
1 week ago
Gurgaon, Haryana, India Johnson & Johnson Innovative Medicine Full time US$ 90,000 - US$ 1,20,000 per yearAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Strategic Regulatory Affairs Director
2 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,20,00,000Job Title: Strategic Regulatory Affairs DirectorAbout the Role:The Global Regulatory Lead will be responsible for formulating, developing, and executing a comprehensive regulatory strategy integrating US and ex-US regulatory requirements and health authority engagements to drive product development, global registration, and ultimately desired labeling for...