Global Regulatory Affairs - Principal
We seek a highly skilled Regulatory Affairs professional to support our efforts in discovering and bringing life-changing medicines to those who need them, improving the understanding and management of disease, and giving back to our communities through philanthropy and volunteerism.
About the Role
The successful candidate will be based within our Regulatory Affairs Department, which plays a critical role in delivering our product pipeline by managing global submissions for both New Chemical Entities (NCEs) and New Molecular Entities (NMEs), as well as global post-approval change management for commercial products, ensuring reliable supply and continuous improvement.
Purpose of the Role
The purpose of this Principal Scientist - Global Regulatory Affairs CMC role is to provide strategic, tactical, and operational direction to expedite CMC development of our portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.
Responsibilities
1. Oversee the preparation and documentation of specified regulatory submissions.
2. Provide regulatory leadership and direction for products listed as primary responsibilities.
3. Manage submission timelines, monitor approval status, and communicate change status to interested personnel in a timely manner.
4. Have a good understanding of existing and emerging pharmaceutical & biotech-related regulations.
5. Provide the necessary CMC commitment information to site personnel.
6. Ensure compliance of GMP documents to regulatory commitments and provide support for batch release process (review/approval deviations, status of approval of change, etc.).
Requirements
* A Level 8 Bachelor's degree in a sciences discipline (e.g., chemistry, biology, biochemistry or pharmacy or related scientific discipline).
* Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
* Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.
Key Skills and Qualities
The ideal candidate will possess strong regulatory expertise, excellent communication skills, and the ability to work collaboratively as part of a global team. They will have a deep understanding of pharmaceutical and biotech-related regulations and be able to provide strategic direction to expedite CMC development.