Associate Director Regulatory Affairs CMC

Associate Director Regulatory Affairs CMC

Requirements

• 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
• Knowledge and understanding of global regulatory CMC requirements and guidelines
• Previous experience in the preparation and submission of the CMC components of IND/CTA and 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 skills
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting
• Demonstrated personal initiative, responsibility, flexibility, and ability to handle multiple project assignments
• Skilled at negotiating with/influencing business partners and departmental leaders
• Adept at communicating a clear vision among team members effectively aligning resources to achieve functional area goals

Responsibilities

• Supports 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
• Organizes and contributes to the timely preparation of high quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for submission to global regulatory authorities
• Contributes as a key regulatory representative with external parties for CMC development activities
• Interacts with regulatory agencies for CMC development activities as required
• 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

Preferred Qualifications

No preferred qualifications provided.