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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
CTC NA
Location Hyderabad
Job Code 1921
Posted On 01 Sep 2021
Application Deadline 01 Dec 2021

Skills


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

Description


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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