POSITION OBJECTIVE: As Associate, Regulatory CMC you will provide support in the execution of CMC regulatory strategies and regulatory submissions (IND, BLA) for cell and gene therapy products as well as critical materials such as vectors and other novel technologies in the US and Rest of World (ROW). You will provide support to other Regulatory CMC staff in the creation of CMC submissions to regulatory authorities (FDA, EMA, PMDA, CFDA).
Essential Job Functions/Responsibilities
- Provide support in communication with regulatory authorities (FDA, EMA, PMDA, CFDA) on CMC regulatory issues; support CMC topics during regulatory meetings
- Responsible for drafting or performing quality control checks of submission content
- Work with Regulatory CMC team on early to late stage development projects
- Represent Regulatory CMC on assigned cross-functional project teams
- Provide current regulatory requirements and evolving/current expectations to technical operations departments
- Develop excellent relationships with internal functional groups, including clinical, technical operations, quality, and other regulatory functions
- Maintains awareness and develop critical expertise with ICH, FDA and EU guidelines related to CMC regulatory topics
- Support departmental initiatives, including special projects, budgeting, and training
Desired Education & Qualifications
- Bachelors degree in cell and gene therapy or related field required
- 3-5 years of experience in regulatory CMC required
- Knowledge of US and international regulatory CMC requirements (general and advanced therapies) and the ability to apply knowledge both strategically and operationally, required
- Relevant years of experience in a global pharmaceutical or biotechnology company with focus in product development, manufacturing or quality, preferred
- Experience assessing manufacturing process changes and managing clinical trial applications over the life of the product
• Experience working with cellular or gene therapy biological products preferred
• Experience working with viral vectors used in the manufacture of cellular or gene therapy biological products preferred
- Outstanding interpersonal and communication skills (written and verbal) is required
- Proficient with computer and standard software programs
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.