CMC Regulatory Strategist

6 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 40,00,000
CMC Regulatory Manager Job Overview

The CMC Regulatory Manager will spearhead the formulation and implementation of global CMC regulatory strategy to maximize business value while ensuring regulatory compliance.

  • Develop and execute global CMC submission activities, encompassing planning, authoring, reviewing, coordination, and submission, for assigned projects/products.
  • Identify necessary documentation and address content, quality, or timeline issues for global submissions, negotiating the delivery of approved technical source documents in line with project timelines.
  • Compose and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current trends, and guidelines.

The incumbent will ensure technical congruence and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements. Additionally, they will prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions, escalating as necessary.

Key performance indicators include producing high-quality strategic project documentation and presentations, minimizing late changes due to inadequate prior evaluation, and delivering reliable, timely, and accurate information about project-specific issues within the department and to key stakeholders.

Desired qualifications include cross-cultural experience, operations management, and collaboration skills, along with expertise in change control, cross-functional teams, documentation management, negotiation, project management, regulatory compliance, risk assessment, and risk management.

Benefits of this role include:

  • Opportunity to work on high-impact projects with a focus on regulatory compliance.
  • Collaborative and dynamic work environment.
  • Professional growth and development opportunities.

Preferred qualifications include proficiency in English language.

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