Lead Global CMC Regulatory Strategy for Biopharmaceutical Products
2 months ago
About the Role
As a Director, CMC Regulatory Affairs, you will play a pivotal role in shaping the global regulatory landscape for GSK's biopharmaceutical products. You will lead a team of experts, ensuring compliance with internal policies and procedures while driving strategic direction and guidance across various departments.
Key Responsibilities
- Develop and execute comprehensive CMC regulatory strategies for new and existing biopharmaceutical products, navigating complex global regulatory requirements.
- Lead cross-functional teams to ensure seamless communication and collaboration throughout the product development lifecycle.
- Provide expert guidance on CMC regulatory submissions, ensuring accuracy, completeness, and adherence to international standards.
- Stay abreast of evolving regulatory trends and industry best practices, proactively identifying opportunities for improvement and innovation.
- Build and maintain strong relationships with key stakeholders, including regulatory agencies, internal departments, and external partners.
About You
You are a highly motivated and results-oriented leader with a deep understanding of CMC regulatory requirements for biopharmaceuticals. Your expertise in regulatory submissions, strategic planning, and cross-functional collaboration will be instrumental in driving the success of GSK's innovative products.
Qualifications
- Advanced degree (PharmD, PhD, or equivalent) in a relevant scientific discipline.
- Extensive experience in CMC regulatory affairs within the biopharmaceutical industry.
- Proven track record of successfully leading and managing complex regulatory projects.
- Strong analytical, communication, and interpersonal skills.
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