Senior Manager, Regulatory Affairs, CMC

We are seeking a Senior Manager of Regulatory Affairs, CMC who will report into the Associate Director of Regulatory Affairs. The individual will be responsible for providing regulatory guidance, ensuring compliance, and developing high-quality regulatory submissions.

Requirements

• Bachelor’s degree in a science or health-related field (like biology, chemistry, or pharmacy); or relevant experience; preferred.
• Eight plus (8 +) years of submission/publishing Regulatory Affairs, Regulatory Operations, or Regulatory Project Management experience in a biotech/pharmaceutical setting.
• Excellent command of GXPs (eg, GMPs, GLPs and GCPs).
• Demonstration of cross-functional understanding related to drug development
• Understanding of all International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA guidance relevant to electronic regulatory submissions.
• Experience and knowledge in the preparation of global regulatory submissions with primary focus on electronic publishing of US IND and/or NDA sequences (additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful).
• Ability to work both independently with direction and within project teams and see all projects through to their completion.
• Excellent verbal and written communication skills.
• Strong organizational skills, including the ability to prioritize workload.
• Strong people skills and the ability to deal effectively with others.
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
• Maintain a positive, approachable, and professional attitude.

Benefits

• Medical, dental, vision insurance
• 401(k) match
• PTO
• Paid holidays