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Regulatory CMC Director
Attractive Remuneration Package
About Our Client
Our client is a clinical-stage biotechnology company focused on the development and commercialization of cancer immunotherapies.
- Responsible for developing and ensuring execution of regulatory CMC activities in line with US regulatory requirements
- Lead and drive all global CMC submission activities, such as planning, authoring, reviewing, coordination and submission.
- Perform gap analysis on CMC regulatory dossiers to ensure completeness for submissions
- Serve as CMC regulatory subject matter expert to product development and technical teams on manufacturing changes, line extensions, technical labelling, to ensure regulatory compliance
- Coordinate and consult with other concerned functions on the content, quality and assembly of regulatory documentation and ensuring consistency, completeness, and adherence to standards for all the regulatory submissions.
- Prepare, compile, review, and process the regulatory submissions including both pre-approval and post approval submissions such as IND, NDA/BLA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
- Attend and participate in the assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations.
- Act as liaison between FDA, the company and other external stakeholders as required
- Anticipate regulatory changes and develops proactive strategy accordingly
The Successful Applicant
- Degree in Science or equivalent
- Minimum 10 years in regulatory preferred, and/or experience in biopharmaceuticals
- Technically competent with deep understanding of CMC submissions
- Excellent working knowledge/experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
- Good people skills
What's on Offer
You will enjoy working in a dynamic environment in this exciting biotechnology start-up where you will be fully responsible for the regulatory CMC activities.