Associate Director, Regulatory Affairs CMC

Role Summary

The Associate Director, Regulatory CMC contributes to and assists with the development and implementation of global regulatory CMC strategies for investigational and marketed small molecule therapeutics. It involves coordinating global CMC regulatory activities, representing regulatory on cross-functional teams, and interfacing with global regulatory agencies to support clinical development and product lifecycle. This role can be based in San Diego, CA or Princeton, NJ, with a hybrid model requiring office presence three days per week on average.

Responsibilities

• Supports CMC regulatory affairs activities for marketed products and development compounds in line with US and ex-US regulatory requirements.
• Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality, Regulatory, and other areas to develop and implement CMC regulatory strategy.
• Prepares high-quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for global submissions to support clinical trials and marketing applications.
• Acts as a regulatory representative with external parties for CMC development activities.
• Interacts with regulatory agencies for CMC development activities as required.
• Provides CMC regulatory guidance and strategy on development teams, including risk assessment and mitigation.
• Ensures compliance of CMC activities with applicable regulatory requirements.
• Evaluates manufacturing processes and changes, assesses regulatory implications, and supports implementation.
• Maintains current knowledge of relevant guidelines and regulations and applies them to company activities.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a life science or related field. At least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development; equivalent education/experience considered.
• Knowledge of global regulatory CMC requirements and guidelines.
• Experience in preparation and submission of CMC components of IND/CTA, NDA and ex-US MAA submissions.
• Ability to work in a cross-functional team environment and manage competing priorities.
• Strong interpersonal skills, attention to detail, and excellent organizational, computer, and documentation abilities. Ability to meet deadlines and handle multiple tasks in a fast-paced setting.
• Initiative, responsibility, flexibility, and ability to work with limited supervision and manage multiple projects.
• Negotiation/influencing skills with business partners and departmental leaders on substantive matters.
• Ability to communicate a clear vision and align resources to achieve functional goals.

Skills

• Global regulatory CMC knowledge and guidelines
• Cross-functional collaboration and project management
• Regulatory strategy development and risk assessment
• Stakeholder communication and external agency liaison

Education

• Bachelor’s degree in a life science or related field

Additional Requirements

• Physical: Regularly stand, walk, sit; use hands; reach; climb/balance; stoop/kneel/crouch; and other standard office activities. Occasional lifting up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.