Regulatory Affairs CMC Co-op

Sarepta Therapeutics • Medford, MA

302d • $22 - $34 • Remote

About The Position

The Global Regulatory Affairs Chemistry, Manufacturing and Control (GRA-CMC) co-opportunity provides students with an overview of Regulatory Affairs (RA) responsibilities including general knowledge of global health authority requirements and guidance to develop regulatory CMC strategies to enable the development and/or lifecycle management of pharmaceutical products. The co-op will receive hands-on experience in developing the skills to prepare various global regulatory CMC submission documents for products in drug development and lifecycle (commercial) space, all while being an active contributor to the GRA-CMC Team. In addition, the co-op will have a unique networking opportunity to manage their own project by working in cross-functional teams outside of GRA-CMC as part of this comprehensive training and immersion program.

Requirements

• Graduate student pursuing a degree in Regulatory Affairs.
• An undergraduate degree in science, technology, or engineering is preferable.
• Fundamental understanding of drug development shown by theoretical experience.
• Knowledge of current Food and Drug Administration (FDA) regulations and guidelines is desired.
• Proven leadership capabilities in an organizational setting (campus/community or employment activities) is desired.
• Able to work independently and be part of a group with curiosity and flexibility.

Responsibilities

• Support projects including change control regulatory assessments.
• Maintenance of regulatory tracking activities in the Veeva systems.
• Provide regulatory submission support for assigned products.
• Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta Standard Operating Procedures (SOPs).
• Develop and maintain knowledge of relevant evolving regulation and guidance.

Benefits

• Competitive compensation and benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Industry: Chemical Manufacturing
• Education Level: Master's degree