
Regulatory Affairs Professional with Lifecycle Expertise
1 day ago
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to serve as an expert individual contributor within our organization. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage and execute highly complex or specialized projects. The Specialist will apply advanced regulatory expertise, adapting precedents and developing innovative approaches to ensure compliance and successful product approvals.
Main Responsibilities:
- Lead the development and preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
- Act as the primary liaison with regulatory agencies to expedite approval of pending registrations and maintain compliance throughout the product lifecycle.
- Provide regulatory guidance during product planning and implementation, regulatory strategy development, risk management, and chemistry manufacturing control (CMC) activities.
- Ensure timely approval of new drugs, biologics, or medical devices, as well as continued approval of marketed products.
- Represent the regulatory function in cross-functional teams, including marketing, research, and technical groups.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory requirements.
Required Skills & Qualifications:
- Excellent understanding of regulatory guidelines and processes.
- Strong project management and problem-solving skills.
- Effective communication and stakeholder management abilities.
- Ability to work independently as a subject matter expert and contribute to cross-functional teams.
About Us:
This is a fantastic opportunity to join a dynamic team and be a part of shaping the future of our industry. As a key member of our team, you will have the chance to make a real impact and contribute to the success of our organization.
What We Offer:
- Opportunity to work with a talented team of professionals
- Comprehensive training and development program
- Collaborative and dynamic work environment
How to Apply:
Please submit your resume and cover letter to us through our website. We look forward to hearing from you
-
Expert Regulatory Affairs Leader
7 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...
-
Regulatory Affairs Expert
3 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 Lead
6 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 Specialist
3 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...
-
Project Manager – Regulatory Affairs
5 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
1 week 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...
-
Regulatory Affairs Specialist
18 hours ago
Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878Job Description:As a Regulatory Affairs professional, you will be responsible for preparing and submitting crucial regulatory documents. Your primary focus will be on Module 1 documents and lifecycle maintenance activities to ensure global compliance.Essential Functions:Regulatory Document PreparationPrepare Module 1 documents and country-specific...
-
Regulatory Affairs Coordinator
1 week 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
7 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...