Global CMC Regulatory Strategy Manager

5 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,80,96,000 - ₹ 2,21,92,000

Job Title:

A Manager is required to lead global CMC regulatory strategy.

The ideal candidate will formulate and implement a proactive approach to maximize business benefit balanced with regulatory compliance.

  • Liaise with cross-functional teams to ensure technical congruency and regulatory compliance.
  • Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions.
  • Initiate and lead Health Authority interactions and negotiations as appropriate.
  • Report technical complaints, adverse events, and special case scenarios related to products within 24 hours of receipt.

Key Requirements include drug product experience, operations management, project management, change control, negotiation skills, regulatory compliance, and risk assessment. To succeed in this role, you should have a strong background in chemistry manufacturing and control (CMC) activities and excellent leadership skills.

  • CMC Regulatory Strategy Lead

    2 days ago

    Hyderabad, Telangana, India beBeeregulatory Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Job Overview:We are seeking a seasoned Regulatory CMC Manager to lead our global regulatory strategy and ensure compliance with all relevant regulations.Key Responsibilities:Develop and implement global CMC regulatory strategies, balancing business benefits with regulatory compliance.Lead global CMC submission activities, including planning, authoring,...

  • Global CMC Regulatory Professional

    11 hours ago

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

    Regulatory Specialist Job OverviewThis role involves preparing and publishing regulatory documentation for health authorities. The individual will interact with these authorities on chemistry, manufacturing, and control (CMC) related questions to support the launch of new or existing products.Main Responsibilities:Create a comprehensive global CMC regulatory...

  • Global CMC Regulatory Expert

    4 days ago

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

    Job Title: Chemistry, Manufacturing and Control Regulatory SpecialistWe are seeking an experienced professional to lead our global Chemistry, Manufacturing and Control (CMC) regulatory strategy. This challenging role requires a strong understanding of regulatory requirements and the ability to develop and implement effective CMC submission activities.Main...

  • Cmc regulatory expert

    2 days ago

    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...

  • Cmc Regulatory Expert

    5 days ago

    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...

  • Cmc Regulatory Specialist

    20 hours ago

    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...

  • Senior Global CMC Regulatory Strategist

    2 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 24,00,000

    Global Regulatory CMC LeadThe role of a Global Regulatory CMC Lead is crucial in ensuring the compliance and success of our products. This position will lead global regulatory strategy, planning, authoring, reviewing, coordination, and submission activities for assigned projects/products.Main Responsibilities:Develop and implement global CMC regulatory...

  • CMC Regulatory Expert

    5 days ago

    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...

  • CMC Regulatory Expert

    3 days ago

    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...

  • CMC Regulatory Specialist

    3 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...