We are at the forefront of global healthcare, dedicated to improving lives with every discovery. Our team spans the globe, committed to bringing innovative medicines to those in need, enhancing disease understanding and management, and contributing positively to communities through philanthropy and volunteer work. At our core, we prioritize human health and well-being, striving to provide hope and improve the quality of life worldwide. We believe in the power of unity, discovery, and putting people first in everything we do.
The Role
We're on the lookout for a visionary Senior Advisor/Director in Global Regulatory Affairs - CMC to join our dynamic team. This role is pivotal in employing your expertise in CMC technical knowledge and regulatory science to shape regulatory CMC strategies and oversee submissions for clinical trials and marketing approvals, specifically for our synthetic molecule portfolio. This includes small molecules, peptides, and oligonucleotides. Your innovative regulatory strategies will be crucial in accelerating the development of our products, bringing new hope to patients globally.
Your Impact
Expertise Required: Deep understanding of synthetic molecule CMC drug development and global regulatory requirements. Your knowledge will guide clinical trials and global product registrations.
Strategic Development: Formulate and adapt regulatory strategies in response to global regulatory shifts. You'll offer regulatory insights to empower CMC development teams, making pivotal decisions that influence the trajectory of product development.
Leadership: Lead the preparation, review, and finalization of CMC documents for global submissions. Your proactive leadership will be key in reviewing molecule-specific CMC development strategies and ensuring alignment across teams.
Who You Are
Educational Background: You hold a B.S. degree (or higher) in Science, Engineering, or a related field. Preferred fields include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
Experience: You bring at least five years of Regulatory CMC experience, with a preference for those who have more extensive experience, especially in synthetic molecules' clinical development phases or commercialization.
Preferred Skills
Proven experience in CMC submission processes and handling regulatory inquiries.
Familiarity with major market regulations and an understanding of evolving regulatory landscapes.
Experience in synthetic molecule development, commercialization, or manufacturing is highly valued.
Exceptional communication skills, both written and oral, and the ability to influence and negotiate.
A strong sense of detail, leadership qualities, and the ability to work effectively in diverse teams.
Additional Information
Travel: Minimal, within the US.
We're dedicated to inclusivity and provide comprehensive support to ensure equal employment opportunities for all, including individuals with disabilities.
Join Us
If you're driven to make a difference in the world, eager to support life-changing innovations, and ready to lead with your expertise, we'd love to hear from you. Together, let's unite caring with discovery to create a healthier, better future for everyone.
Employment Type: Full-Time
Salary: $ 75,000.00 Per Year
