Cmc Regulatory Expert
4 days ago
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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