Regulatory Affairs Specialist

2 days ago

Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Regulatory Affairs Specialist

We 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 degree in pharmaceutical sciences and experience in a regulatory support role, demonstrating excellent communication and organizational skills.

This is a key opportunity for an individual to develop their career in regulatory affairs and contribute to the success of our organization.

Key Responsibilities:
  • Regulatory Document Preparation:
    • Assist with the preparation of Module 1 documents and the collection of country-specific administrative forms.
    • Aid in preparing various regulatory submission documents, including components of investigational new drug applications (INDs), new drug applications/marketing authorization applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, and marketing authorization transfers (MATs).
    • Prepare responses to Health Authority queries and track Health Authority commitments.
  • Tracking and Archiving:
    • Maintain and update regulatory trackers, submission timelines, and status reports.
    • Ensure proper archiving of submission documentation and compliance with internal SOPs.
  • Regulatory Research & Support:
    • Conduct regulatory research to identify precedents and support the preparation of orphan drug designation requests.
    • Assist clients and customers with general information requests.
    • Gather information from files, records, and contacts to prepare detailed reports and routine correspondence.
Requirements:
  • Education: A Master's degree in Pharmaceutical Sciences.
  • Experience: A minimum of approximately 2 years of experience in a regulatory, quality, or document management support role.
  • Skills:
    • Excellent interpersonal and communication skills.
    • Advanced proficiency in Microsoft Office Applications.
    • Good time and project management skills are preferred.

  • Regulatory Affairs Specialist

    1 day ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 50,00,000 - ₹ 75,00,000

    Regulatory 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...

  • Regulatory Affairs Coordinator

    1 day ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000

    Regulatory 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...

  • Expert Regulatory Affairs Leader

    16 hours ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000

    Senior 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...

  • Manager - Regulatory Affair

    4 weeks ago

    Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

    JOB DESCRIPTION Position Manager Senior Manager Job Location Gurgaon Education M Pharm Department Global Regulatory Affairs Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets...

  • Assistant Manager- Regulatory affairs

    4 days ago

    Gurgaon, Haryana, India Johnson & Johnson Innovative Medicine Full time US$ 90,000 - US$ 1,20,000 per year

    At 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...

  • Public Policy and Regulatory Affairs Leader

    2 days ago

    Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 1,80,00,000 - ₹ 2,52,00,000

    Job Summary:We are seeking an experienced public policy and regulatory affairs professional to lead our team in India.This role requires a seasoned expert with 15 years of experience in MNCs, consultancies, government agencies or similar with a deep understanding of Indian politics and government affairs.The ideal candidate will have a master's degree in...

  • Urgent: Regulatory Affairs Lead, India

    3 weeks ago

    Gurgaon, Haryana, India Takeda Full time

    By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and I further attest that all information I submit in my employment application is true to the best of my knowledge Job Title Regulatory Affairs Lead ...

  • Deputy Manager Regulatory Affairs

    3 weeks ago

    Gurgaon, Haryana, India Haleon Full time

    Job Description- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.- Continuously looking for opportunities to learn, build skills and share learning.- Sustaining energy and well-being-...

  • Senior Regulatory Compliance Expert

    2 days ago

    Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000

    Job SummaryWe 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...

  • Head Of Public Policy And Regulatory Affairs India

    2 days ago

    Gurgaon, Haryana, India Maersk Full time

    At Maersk we believe in an integrated world Connected all the way We provide our customers with a simple end-to-end offering of products and services through a superior delivery network at sea on land and in the air taking the complexity out of supply chains and thereby improve the flow of foods goods data and materials to sustain people businesses ...