The Director, Regulatory CMC, is responsible for developing, leading, and implementing global regulatory CMC strategies supporting the development and commercialization of small molecules therapeutics worldwide. Leads global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products. Represents the regulatory function on multi-disciplinary CMC product development teams and acts as the point of contact with global regulatory agencies. Serves as a resource to the CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development and commercial activities.

Primary Responsibilities

• Manages the CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.
• Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy.
• Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities including FDA, EMA, Health Canada and other national authorities, to support the conduct of clinical trials and marketing applications.
• Contributes as a key regulatory representative with external parties for CMC development activities.
• Acts as a point of contact with regulatory agencies for CMC development activities.
• Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.
• Participates in ensuring compliance of CMC activities with applicable regulatory requirements.
• Evaluates Manufacturing processes and changes, assesses the regulatory implications and supports their implementation.
• Maintains current knowledge of the relevant guidelines and regulations and determine applicability to company activities.
• Other duties as assigned.

Education and Experience

• Bachelor's degree in a life science or related field.
• Targeting 10 years progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development with 5 years in a management role.
• An equivalent combination of relevant education and applicable job experience may be considered.
• Knowledge and understanding of global regulatory CMC requirements and guidelines.
• Previous experience in the preparation and submission of the CMC components of IND/CTA filings as well as regulatory authority meeting Briefing Packages and NDA and ex-US MAA submissions.
• Ability to work in a cross-functional team environment and manage competing priorities.
• Strong interpersonal skill, attention to detail and excellent organizational, computer, and documentation.
• Ability to meet deadlines and perform multiple tasks in a fast paced setting.
• Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and ability to handle multiple project assignments.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight up to 30% of the time and work after hours if required by travel schedule or business issues.