Senior Regulatory Affairs Specialist

3 weeks ago

Hyderabad, Telangana, 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 data.
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Key Requirements:

  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  • Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  • Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

  • Senior Regulatory Affairs Specialist

    4 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time

    Job 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...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Senior Regulatory Affairs Specialist - SpineJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking...

  • Regulatory Affairs Expert

    2 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Senior 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...

  • Sr. Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Sr Regulatory Affairs Specialist - ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose ...

  • Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Thepharmadaily Full time

    Job 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...

  • Urgent: Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist - II-ETJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...

  • Regulatory Affairs Specialist Ii

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist IIJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...

  • Urgent: Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist - IIJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...

  • Regulatory Affairs Specialist- Et-hyderabad

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist- ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down...

  • Regulatory Affairs Specialist-ii-et

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist-II-ETJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...