CMC Regulatory Specialist

2 days ago


Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 17,50,000

Job Summary:

-Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.

Key Responsibilities:

  • Develop a comprehensive global CMC regulatory strategy that balances innovation with compliance.
  • Lead the planning, authoring, reviewing, coordination, and submission of global CMC documents for assigned projects/products.
  • Prepare high-quality CMC documentation for health authority submissions by applying agreed-upon global regulatory strategies, current trends, and guidelines.
  • Ensure the technical congruency and regulatory compliance of submitted documents, meeting agreed timelines and e-publishing requirements.
  • Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned for major submissions and escalate as necessary.
  • Initiate and lead interactions with health authorities, setting objectives, preparing briefing books, coordinating rehearsals, and risk mitigation plans.

Requirements:

  • Experience working with drug products is essential.
  • Operational management and execution are crucial.
  • Collaboration across teams is vital.
  • Project management skills are necessary.
  • Negotiation, project management, and regulatory compliance are key.


  • Hyderabad, Telangana, India BeBeeRegulatory Full time

    Job Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities.This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,00,00,000

    Regulatory Activities ManagerThis role is responsible for overseeing regulatory activities related to chemistry, manufacturing, and control (CMC) of products. Key tasks include preparing and publishing CMC documentation for submissions to Health Authorities, as well as interacting with HA's on CMC questions to support new product or post-marketed launches.


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Regulatory CMC ProfessionalWe are seeking a highly skilled Regulatory CMC Professional to join our team.Key Responsibilities:Prepare and publish REG CMC documentation for submissions to Health AuthoritiesInteract with Health Authorities on REG CMC questions to support new product or post-marketed launchesThe ideal candidate will have strong knowledge of...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,15,000

    Regulatory Expert for Chemistry, Manufacturing and ControlWe are seeking a skilled professional to lead global CMC submission activities.About the Role:This challenging position requires a strong understanding of regulatory requirements and technical expertise in chemistry, manufacturing, and control.Main Responsibilities:Develop strategic plans for global...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    About Our CMC Regulatory Role:Seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to lead global CMC submission activities.Develop and implement strategic plans for global CMC regulatory submissions.Lead and manage global CMC submission projects.Author high-quality CMC documentation for health authority submissions.Ensure...


  • Hyderabad, Telangana, India BeBeeRegulatory Full time

    Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...


  • Hyderabad, Telangana, India BeBeeRegulatory Full time

    Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team.This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities.The ideal candidate will have...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 43,33,814 - ₹ 86,67,628

    Job Title: Chemistry, Manufacturing and Control Regulatory Expert-We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...


  • Hyderabad, Telangana, India beBeeRegulatory Full time

    Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000

    Regulatory Affairs Expertise for CMC SubmissionsIn this role, you will lead and manage key activities related to CMC regulatory submissions for USFDA purposes. This includes preparing, reviewing, and filing ANDA documents. You will also oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.You will work closely with...