CMC Regulatory Affairs Specialist

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
About the Job

As a CMC Regulatory Strategy Manager, you will be responsible for formulating and leading global CMC regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance.

You will lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. This includes identifying required documentation and content, quality, and/or timelines issues for global submissions and negotiating 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 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.

Key Performance Indicators:

  • Produces high-quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.
  • No delays in approvals of clinical studies, global registration dossiers, or variations due to late or inadequate submission documentation on matters within RA CMC control.
  • Delivers reliable, timely, and accurate information/communication about project-specific issues within own department and to key stakeholders—RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
  • Provides high-quality regulatory evaluation and strategic advice on time (change control, etc); regulatory compliance met in all compliance systems.
  • Maintains collaborative partnerships with stakeholders.

Work Experience:

  • Cross-Cultural Experience.
  • Operations Management and Execution.
  • Collaborating across boundaries.
  • Project Management.

Skills:

  • Change Control.
  • Cross-Functional Teams.
  • Documentation Management.
  • Negotiation Skills.
  • Project Management.
  • Regulatory Compliance.
  • Risk Assessment.
  • Risk Management.
Required Skills and Qualifications

This role requires a strong background in CMC regulatory affairs, with experience in managing global submissions and developing regulatory strategies.

The ideal candidate will possess excellent communication and negotiation skills, with the ability to work effectively in cross-functional teams.

A bachelor's degree in a life sciences field is required; a master's degree or Ph.D. is preferred.

The candidate should also have experience with change control, risk assessment, and regulatory compliance.

Benefits

This role offers a competitive salary and benefits package, including health insurance, retirement savings plan, and paid time off.

The company also offers opportunities for professional growth and development, with training programs and mentorship available.

Others

As a CMC Regulatory Strategy Manager, you will have the opportunity to work on exciting and challenging projects, with the potential to make a significant impact on the company's success.

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