Associate Director Regulatory CMC
2 weeks ago
We are a pioneering biotech company dedicated to revolutionizing cancer treatment with innovative oncolytic immunotherapies. Our mission is to boldly transform cancer care and make a meaningful impact on patients' lives.
About the RoleThis is an exciting opportunity to join our team as an Associate Director, Regulatory CMC, where you will play a critical role in ensuring the preparation and submission of high-quality regulatory documents to regulatory agencies. You will be responsible for coordinating the preparation of documentation packages, reviewing and managing CMC regulatory documentation, and maintaining regulatory documentation.
Key Responsibilities- Prepare and coordinate the preparation of documentation packages for regulatory submissions, including IND, BLA, CTA, and other submissions.
- Review and manage CMC regulatory documentation, including submissions to and correspondence with regulatory agencies.
- Maintain regulatory documentation, including submissions to and correspondence with regulatory agencies.
- Coordinate the collection of information from other departments for incorporation into regulatory submissions.
- Review CMC and technical documentation for regulatory compliance.
- Develop and maintain current regulatory knowledge and implement changes required for regulatory compliance.
- Perform other administrative duties as necessary.
- B.A or B.S. degree in an appropriate scientific field.
- 10-15 years of experience in the Pharmaceutical/Biotech Industry with 8-10 years in a Regulatory Affairs/Regulatory Operations capacity.
- Knowledge and practical understanding of ICH Guidelines, GMP/GCP, and CBER and/or CDER requirements.
- Previous participation in preparing regulatory submissions to the FDA and EU Regulatory Authorities.
- Solid understanding of the e-CTD specifications for electronic submissions.
- Strong technical writing and documentation preparation/publishing skills.
- MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio.
- Strong interpersonal, organizational, and time management skills.
- Ability to handle matters of strict confidentiality and sensitivity.
- Appropriate GXP training.
We offer a competitive and forward-looking total rewards program, a collaborative and innovative culture, and a unique opportunity to contribute to the meaningful work we do. If you are passionate about transforming cancer treatment and making a meaningful impact on patients' lives, we encourage you to apply for this exciting opportunity.
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