CMC Regulatory Expert

4 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time

Job Title: Chemistry, Manufacturing and Control Regulatory Expert

-We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have experience in formulating and leading global CMC regulatory strategies, authoring high-quality CMC documentation, and ensuring technical congruency and regulatory compliance.

Key Responsibilities:

  • Develop and implement global CMC regulatory strategies that balance business needs with regulatory requirements.
  • Lead and manage global CMC submission activities, including planning, authoring, reviewing, coordination, and submission.
  • Author and/or review high-quality CMC documentation for health authority submissions.
  • Ensure technical congruency and regulatory compliance across all regions.
  • Collaborate with cross-functional teams to identify and address quality and compliance issues.
  • Prepare and communicate CMC risk management assessments and contingency plans.

Requirements:

  • Pharmaceutical industry experience with a focus on chemistry, manufacturing, and control.
  • Strong knowledge of regulatory requirements and guidelines, particularly those related to CMC.
  • Proven track record of leading global CMC submission activities.
  • Excellent communication and project management skills.
  • Bachelor's degree in a relevant field, such as pharmaceutical science or chemistry.

Benefits:

  • We offer a competitive salary and benefits package, including comprehensive health insurance and a 401(k) plan.
  • Ongoing training and development opportunities to help you grow your career.
  • A dynamic and collaborative work environment with a diverse team of professionals.

Why Join Our Team?

We are a leading company in the pharmaceutical industry, dedicated to delivering innovative medicines and improving patient outcomes. As a member of our team, you will have the opportunity to make a meaningful contribution to our mission and advance your career in a fast-paced and exciting industry.

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