Associate Director Regulatory CMC
My client is an exciting, innovative drug development company with marketed products world-wide.With two major development partnerships in place, they anticipate a 50% increase in growth in the coming year. They are seeking an Associate Director Regulatory CMC to assist the Head of Regulatory CMC in support of CMC sections with FDA and ex-US agencies world-wide. You should be solutions-oriented, analytical, and have a high level of intellectual curiosity as it pertains to regulatory development.
Responsibilities
- Develop and implement regulatory strategy
- Represent the regulatory CMC related to cross-functional development teams as well as external pharmaceutical partners
- Assess and communicate regulatory requirements for submissions and programs to ensure that all development activities are in compliance with applicable regulations and guidelines.
- Provide regulatory guidance and strategy including identification and assessment of regulatory risks
- Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications and all related amendments (IND, CTA, NDA, and MAA)
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
Knowledge and Skills
- Minimum BS/BA in scientific discipline required
- Minimum 6-8 years of Regulatory Affairs experience within the biotech or pharmaceutical industry
- Must have knowledge and understanding of global regulations and guidelines
- Previous experience in the preparation and submission of regulatory documents (IND/CTA/NDA/MAA)
- Experience with investigational, including late stage development, and/or marketed products
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively