CMC Regulatory Expert
4 weeks ago
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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