Chemistry Manufacturing Compliance Manager

2 days ago

Hyderabad, Telangana, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title

 

Job Description Summary

Regulatory activities specifically related to chemistry, manufacturing, and control (CMC) are critical components of our organization's operations. The preparation and publication of REG CMC documentation for submissions to Health Authorities are key tasks in this area. Additionally, interacting with Health Authorities on REG CMC questions is essential for supporting new product or post-marketed launches.

Major Accountabilities:

  • Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance. Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
  • Identify required documentation and any content, quality, and/or timelines issues for global submissions. Negotiate 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.
  • Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions. 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.
  • Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt. Distribute marketing samples (where applicable).

Required Skills and Qualifications:

  • Drug product experience is mandatory.
  • Operations Management and Execution.
  • Collaborating across boundaries.
  • Project Management.
  • Change Control.
  • Cross-Functional Teams.
  • Documentation Management.
  • Negotiation Skills, Project Management, Regulatory Compliance.
  • Risk Assessment.

Benefits

This role offers the opportunity to work on complex regulatory challenges and contribute to the success of our organization.

Others

This position requires excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.

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