Senior Regulatory Affairs Specialist

2 days ago


Delhi, Delhi, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

Regulatory Affairs Specialist

Job Description:

We are seeking a detail-oriented and skilled professional to join our dynamic team in Delhi. The ideal candidate will be responsible for supporting the preparation, compilation, review, and submission of high-quality regulatory dossiers for various product types in accordance with regulatory requirements.

Key Responsibilities:
  • Regulatory Dossier Preparation:
  • Understanding of various types of applications on online portals
  • Able to prepare and manage submissions on online portals
  • Hands-on experience in tracking applications on online portals and discussing with local regulatory authorities
Coordination with Regulatory Authorities:
  • Strategic Coordination:
  • Able to coordinate with local regulatory authorities regarding strategies for filed applications
  • Able to communicate with CFT members about updated requirement information from local authorities
  • Regular follow-up with local regulatory authorities for inspections, query responses, and approvals
Regulatory Database Maintenance:
  • Data Management:
  • Maintaining detailed records of licenses, approval letters, inspection letters, and query compliance responses
  • Preparing and sharing periodic status reports on pending applications and approvals
Candidate Profile:
  • Reasonable understanding of regulatory guidelines (NDCT Rules, ICH, WHO, Schedule M, Schedule L etc.)
  • Familiarity with dossier preparation for Oral, Non-orals, Biologics
  • Fair understanding of Indian regulators' requirements for grant of various approvals


  • Delhi, Delhi, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 24,50,000

    Job Title:Senior Regulatory Affairs Specialist


  • Delhi, Delhi, India beBeeEODB Full time ₹ 8,00,000 - ₹ 12,00,000

    Regulatory Affairs SpecialistThis role involves collaborating with industry members to gather inputs on regulatory challenges and leading the development of policy notes and white papers to improve the business environment in India.The position requires identifying cross-cutting industry-wide regulatory bottlenecks through analysis of member inputs,...


  • Delhi, Delhi, India vueverse. Full time

    Key Responsibilities :Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing .Oversee compilation and submission of Annual Reports , amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and...


  • Delhi, Delhi, India WhiteCrow Research Full time

    About are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our clients in-house our clientOur client...


  • Delhi, Delhi, India beBeeNutrition Full time US$ 60,000 - US$ 85,000

    Senior Regulatory Affairs Professional">The role of the Senior Regulatory Affairs Specialist is instrumental in driving the mission to represent and support the food and beverage industry across Asia. This specialist will be responsible for monitoring regulatory developments, providing expert guidance on health and nutrition policies, and supporting...


  • Delhi, Delhi, India Tata Play Ltd Full time

    ROLE SUMMARY Ensure Regulatory compliances and handle Government Affairs KEY DUTIES AND RESPONSIBILITIES Legal expertise in Media & Entertainment industry. We prefer a person with experience in Broadcasting sector or who has worked with a Law firm handling Broadcasting issues. Interact and be a bridge between Tata Play and TRAI, MIB, DoT, Industry bodies...


  • Delhi, Delhi, India Novo Nordisk Full time

    By continuing to use and navigate this website you are agreeing to the use of cookies Accept Close Press Tab to Move to Skip to Content Link Search by Keyword Search by Location Loading Category Select how often in days to receive an alert xc3x97 Select how often in days to receive an alert Senior Manager Government...

  • Head of Legal Affairs

    3 weeks ago


    Delhi, Delhi, India Pathways World School Full time

    Company : RPJ Holdings (P) Ltd (promoter of Pathways World School, Gurgaon) Job Title : Head of Legal and Corporate Affairs Location : Corporate Office on Main MG Road, Radisson Commercial Tower, New Delhi Reports To : CFO and Promoter Directors Requirement : We are seeking an experienced and strategic Head of Legal and Corporate Affairs to lead the...


  • Delhi, Delhi, India beBeeExpertise Full time US$ 1,00,000 - US$ 3,00,000

    International Affairs SpecialistThe European Institute is an independent research center focused on international affairs and debating global relations.Currently, we are concentrating on South Asia's politics, military strategies, defense systems, and diplomacy. To support our growth initiatives, we seek researchers with expertise in these domains.Key...

  • Regulatory Affairs

    3 days ago


    Delhi, Delhi, India vueverse. Full time

    Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...