Global CMC Regulatory Affairs Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time US$ 1,20,000 - US$ 1,60,000
Regulatory Affairs Manager Role

This role is ideal for a highly motivated individual with strong knowledge of FDA CVM and EMA guidelines, experience with CMC registrations in the US and Europe, and excellent communication and organizational skills.

The successful candidate will be responsible for developing regulatory strategies, overseeing submission preparation, and meeting reporting requirements for maintaining registrations and approvals with global regulatory agencies.

  • Maintain effective collaboration and partnership with internal groups in R&D, Quality, and manufacturing teams
  • Lead the preparation of high-quality CMC submissions to multiple geographies, ensuring compliance with global regulatory strategies
  • Communicate regulatory strategy, key issues, and critical topics throughout the project lifecycle, facilitating cross-functional teamwork
  • Author high-quality CMC documentation for submission, applying regulatory expertise and ensuring compliance

This position requires strong leadership and analytical skills, with the ability to handle multiple projects at different phases of development simultaneously.

A minimum of 5 years of experience in Global Regulatory Affairs, preferably in Post-approval CMC Life Cycle Management, is required for this role. The ideal candidate will possess excellent communication and organizational skills, with the ability to work effectively in a fast-paced environment.

We are looking for a dedicated and results-driven individual who can make a significant contribution to our organization. If you have the necessary skills and experience, we encourage you to apply for this exciting opportunity.

  • Global CMC Regulatory Associate

    3 days ago

    Bengaluru, Karnataka, India Eli Lilly Full time US$ 90,000 - US$ 1,20,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Regulatory Affairs Specialist

    2 days ago

    Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 18,00,000

    Job Title:Global Regulatory Affairs SpecialistDescription:We are seeking a highly skilled Global Regulatory Affairs Specialist to support end-to-end submissions for global markets, including lifecycle management (LCM), Veeva Vault RIM, and complex initial and variation submissions.Responsibilities:Prepare variation documents and/or evaluate post-approval CMC...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...

  • Associate Manager –global Cmc Regulatory

    3 days ago

    Bengaluru, Karnataka, India Elanco Full time

    At Elanco NYSE ELAN - it all starts with animals As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets Were driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the...

  • Expert Regulatory CMC

    1 week ago

    Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Your Role:Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as...

  • Expert Regulatory CMC

    4 days ago

    Bengaluru, Karnataka, India Merck Healthcare Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.RESPONSIBILITIES:• Plan and manage development of high quality regulatory...

  • Regulatory Affairs Specialist

    1 week ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Position SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...

  • Senior Specialist _ Regulatory Affairs

    2 days ago

    Bengaluru, Karnataka, India The businesses of Merck KGaA, Darmstadt, Germany Full time ₹ 7,00,000 - ₹ 12,00,000 per year

    Your Role: To provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jour-fixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables Update and review CMC specific documentation, incl. coordination with countries to compile local CMC...

  • Regulatory Affairs Specialist

    7 days ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations...