Associate Director, Regulatory Affairs CMC

Role Summary

Associate Director, Regulatory CMC. Contributes to the development and implementation of global regulatory CMC strategies for investigational and marketed small molecule therapeutics; coordinates global CMC regulatory activities to support clinical trials, regulatory approvals, and product lifecycle; represents regulatory function on CMC development teams and interfaces with global agencies.

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 submissions to global regulatory authorities.
• Serves 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 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 determines applicability 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, or equivalent combination of education and experience.
• Knowledge of global regulatory CMC requirements and guidelines.
• Experience in preparation and submission of CMC components of IND/CTA and 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.
• Demonstrated initiative, responsibility, flexibility, and ability to handle multiple projects with limited supervision.
• Negotiation/influencing skills with business partners and leaders; ability to align resources to achieve goals.

Skills

• Regulatory strategy and planning
• CMC regulatory submissions (IND/CTA, NDA, MAA)
• Cross-functional collaboration
• Regulatory risk assessment and mitigation
• Global regulatory affairs knowledge

Education

• Bachelor’s degree in life sciences or related field.

Additional Requirements

• Ability to travel independently overnight; ability to work after hours if required by travel schedule.