DIRECTOR REGULATORY AFFAIRS CMC BIOLOGICS, REMOTE
LOCATION
US, East Coast
Remote
EMPLOYMENT TYPE
Full-Time Permanent
Posting Date: 15.03.2024
We have an exciting opportunity for a Director Regulatory Affairs CMC to join a growing biotechnology company in the East Coast, US. This position can be fully remote. Our client is an ambitious cell & gene therapy biotechnology company with several products in development and a team passionate about science and innovation.
The Role
As a Director Regulatory Affairs CMC, you will be responsible for developing and leading the Reg CMC strategies across our client’s development portfolio. Working in a matrix environment you will ensure alignment across the organisation of product development plans with global regulations. You will drive the preparation and execution of regulatory CMC modules for submissions.
Main Responsibilities
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Define and lead the execution of global regulatory CMC strategies from early stage to marketing authorisation, in alignment with the product development plan.
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Providing strategic and operational regulatory CMC expertise and support in cross-functional program teams.
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Lead the preparation, drafting, authoring, review, and delivery of regulatory CMC content to regulatory submissions in compliance with global regulatory guidelines – INDs/IMPDs, CTAs, BLAs/MAAs.
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Lead communication and negotiation with international regulatory authorities, alongside clinical regulatory affairs, on key CMC matters.
Requirements
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Advanced degree in a scientific discipline is preferred, with 7+ years of regulatory CMC biologics experience. Alternatively, BSc with 10+ years of relevant experience.
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Preference for prior experience with regulatory CMC cell & gene therapies.
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Experience developing regulatory CMC strategy and extensive experience in preparing and reviewing regulatory CMC documents.
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Expert knowledge and in-depth understanding of drug development, CMC regulations and guidelines. Experience communicating effectively with international health authorities.
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Excellent written and oral communication skills, strong presentation skills.
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Track record of excellent teamwork, cross-functional leadership and ability to build relationships with various stakeholders internally and externally.
The company encourages a merit-based culture of mutual respect and support.
On offer is a comprehensive and competitive benefits plan, including a strong basic salary, annual bonus, retirement plan and stock options. In addition, our client offers a collaborative and merit-based environment to work in, where one can grow and develop personally and professionally. This company is an Equal Opportunity employer and an inclusive company that believes that diversity drives innovation.
Get in touch with Oli Dimitrov for more information on oli.dimitrov@anttalent.com, on +44 208 135 5914, or click on the apply button to send us your CV or register your interest. We will be in touch as soon as possible.