Associate Director, Regulatory Affairs CMC

Role Summary

Associate Director, Regulatory CMC responsible for contributing to/assisting with global regulatory CMC strategies for investigational and marketed small molecule therapeutics. Represents regulatory function on multidisciplinary CMC teams and interacts with global regulatory agencies. Serves as a resource on regulatory requirements, processes, and logistics for global drug development and commercial activities.

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 and Regulatory colleagues to develop and implement CMC regulatory strategy.
• Prepares high-quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for submission to global regulatory authorities, supporting 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 within development teams, including identifying and mitigating regulatory risks.
• Ensures compliance of CMC activities with applicable regulatory requirements.
• Evaluates manufacturing processes and changes, assesses regulatory implications, and supports implementation.
• Maintains knowledge of relevant guidelines and regulations and its applicability to company activities.
• Other duties as assigned.

Education

• Bachelor’s degree in a life science or related field. At least 8 years of progressively responsible experience in CMC Regulatory Affairs focused on small molecule drug development; equivalent education/experience may be considered.

Qualifications

• Knowledge of global regulatory CMC requirements and guidelines.
• Experience preparing and submitting CMC components of IND/CTA, NDA and ex-US MAA submissions.
• Ability to work in a cross-functional team and manage competing priorities.
• Strong interpersonal skills, attention to detail, and excellent organizational, computer, and documentation skills; ability to meet deadlines in a fast-paced setting.
• Initiative, responsibility, flexibility, ability to work with limited supervision, and ability to handle multiple projects.
• Negotiation/influence skills with business partners and departmental leaders.
• Ability to communicate a clear vision and align resources to achieve functional goals.

Skills

• Regulatory strategy development
• CMC regulatory affairs
• IND/CTA/NDA/MAA submissions
• Cross-functional collaboration
• Regulatory risk assessment and mitigation

Education / Certifications

• Bachelor’s degree in life sciences or related field (as above).

Additional Requirements

• Physical requirements: standard office environment; occasional lifting up to 15 pounds; ability to travel independently overnight and work after hours if required by travel schedule.