Associate Director, Regulatory CMC
Senior Director, Regulatory CMC
The Associate Director, Regulatory Affairs, CMC will be responsible for the execution of the company’s Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. This team member will represent the regulatory team and work with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and will represent and support the interface between CMC subject matter experts (SMEs) and Regulatory Affairs/Operations. Key responsibilities will include assisting in the development and filings for CMC modules/updates, including life cycle management; and contributing to the generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for the company. This position reports directly to the Senior Director, Regulatory CMC.
Duties and responsibilities
- Lead in the preparation and internal review of CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings)
- Attend project team meetings and provide CMC-related regulatory input to other functional areas, including Manufacturing, Quality, and Commercial Operations
- Work closely with development, QA, and other stakeholders to define CMC strategy
- As assigned coordinate and develop CMC regulatory projects including generation of budget, timelines, and submission planning
- Preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards
- Preparation of responses to health authority comments and questions pertaining to CMC issues
- Assist in life cycle management for marketed products on a global basis, including regulatory impact assessments and preparation of CMC documentation for variations and other post marketing submissions
- Work with external resources such as contractors/consultants and internal customers to ensure the activities are completed according to approved budgets and timelines
- Prepare Requests for Proposal (RFPs) and help identify and select local regulatory consultants as needed
- Develop and maintain current CMC regulatory knowledge in countries/regions of interest and advise management of significant developments
- Bachelor's degree in a scientific discipline is required, advanced degree is preferred
- A minimum of 6 years of experience in regulatory affairs with a focus on CMC documentation and CMC life-cycle management within the pharmaceutical or biotechnology industry is a must; experience in orphan drugs desired; experience in vaccine and/or gene therapy submissions preferred
- Experience in preparation and submission of CMC modules in eCTD format, including variations and supplements, in the US, EU and at least one international region (e.g., LATAM, APAC) is required
- Working knowledge of FDA and EMA CMC guidance documents and regulations as well as working knowledge of international (e.g., LATAM and APAC) CMC requirements for investigational and marketed products is required
- Must demonstrate experience managing regional consultants successfully
This position operates in an office setting and may include 20% of travel.
This position is largely sedentary. There is an expectation of on-site presence at the company’s headquarters once per month.
As the organization grows there is a requirement to manage direct reports