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Director, CMC & Regulatory Affairs
DEPARTMENT: Product Development
POSITION REPORTS TO: Vice President, Product Development
JOB TYPE: Full Time
Juventas Therapeutics is a venture-backed, clinical-stage biotechnology company developing novel gene therapies for treatment of cardiovascular disease currently being investigated in Phase II clinical trials.
The Director, Regulatory Affairs &CMC will be responsible for development of Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans to transition the product to commercial manufacturing. He/she will develop, review and approve CMC procedures, policies, and guidelines, including the preparation and maintenance of regulatory SOPís. He/she will be responsible for the submission of high quality regulatory documents and briefing packages to FDA as well as other global regulatory bodies. This individual will report directly to the Vice President of Product Development and be comfortable working in a fast-moving, highly-dynamic startup environment are a must.
The successful candidate will have experience in managing biologics (gene therapy preferred) CMC, interacting with the FDA and other global regulatory bodies, and, developing Standard Operating Procedures (SOPs), He/she will be highly organized and capable of working within a team to assure assignments are completed on time. Key responsibilities will include management of transition of product to Phase III/commercial manufacturing, developing/reviewing CMC and quality system SOPs, preparing CMC regulatory submissions to regulatory bodies, and maintaining product files. The position will require interaction with and management of contract manufacturers, oversight of manufacturing processes and assay development, and direct interaction with regulatory agencies. In addition, candidates must have flexibility to take on new tasks as they arise within the company. Highly developed written and oral communication skills, organizational skills, attention to detail, and effective computer skills are required.
Education, Knowledge, Skills and Abilities
The successful candidate will have an advanced degree in an appropriate scientific discipline, or a bachelorís degree with significant regulatory experience. Strong technical writing skills are a must and experience working with the FDA is required.
The candidate must have experience managing CMC regulatory affairs, preferably for biologics in industry and a comprehensive understanding of Good Manufacturing Practices, especially as it relates to manufacturing of biologics. Previous experience working with the Center for Biologics Evaluation and Research (CBER) is strongly preferred, previous work with European guidelines and regulations are a plus. Previous manufacturing auditing experience and knowledge of pharmaceutical development, including biologic processes and analytical method development are a plus. The proper candidate will be a self-starter and willing to work in a dynamic, high-paced start-up environment.
Required Length and Type of Experience
The successful candidate will have M.S. or PhD degree with at least 5 years regulatory experience or B.S. with at least 10 years regulatory experience at a pharmaceutical/biotechnology company. Knowledge of FDA regulatory submission requirements is essential
PRINCIPLE DUTIES AND RESPONSIBILITIES:
1. Preparation of CMC regulatory submission for FDA, including End of Phase II
2. Development of transition plan to Phase III/commercial manufacturing, including CMO sourcing and qualification.
3. Ongoing management of CMO and any other relevant vendors or contractors
4. Preparation/review of regulatory submissions, including CMC amendments and annual reports
5. Development and management of quality management system and CMC SOPs
6. Maintenance of product files
7. Other tasks as assigned
Juventas Therapeutics, Inc.
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