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Regulatory Affairs, CMC

 Hyderabad  7  1921

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Job Details

Company Global Healthcare Company
Position Regulatory Affairs, CMC
Required Experience 7-10 Years
Location Hyderabad
Job Code 1921
Posted On 01 Sep 2021
Application Deadline 01 Dec 2021


CMC,regulatory strategy,Risk Management Assessment,Regulatory Operations,Pharmaceutical


Your responsibilities include but not are limited to:

  • Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities.
  • In addition interact with HA's on REG CMC questions to support new product or post marketed launches.
  • Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
  • Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
  • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams as appropriate.
  • Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
  • Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.       

What You’ll bring to the role :

  • University or College Degree in any field or life science with relevant industry experience or comparable degree.
  • At a minimum 7 years’ experience in the Pharmaceutical area, specifically in Regulatory Operations
  • Good communication in English (oral and written).
  • Knowledge of Regulatory guidelines for the areas mentioned above
  • Organizational awareness and experience working cross-functionally and in global teams is a plus
  • Ability to work under pressure, demonstrating initiative and flexibility
  • Attention to detail and quality focused
  • Team-minded

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