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Senior Manager of Regulatory Affairs

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ArriVent Biopharma is looking for a talented and highly motivated regulatory affairs individual contributor to execute global regulatory strategies aimed at the most efficient regulatory pathway for oncology drug and/or diagnostic development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects. This position is primarily remote, however, will require working closely with a cross-functional team based in the San Francisco Bay area. Some travel to the Burlingame, CA office will be required.

Key responsibilities:

• Formulate regulatory implementation strategies, with supervisor oversight
• Collaborate with cross-functional project teams and external partners
• Manage coordination, preparation, and timely submission of regulatory documents and filings – including creating and maintaining regulatory submission content plans, timelines, submission strategies, and establishing submission structure in electronic common technical document format
• Review regulatory submissions for consistency and quality across regions
• Manage preparation of responses to queries from regulatory authorities
• Manage and track commitments to health authorities for assigned projects
• Represent regulatory affairs at cross-functional meetings, as relevant
• Maintain up to date knowledge and expertise with FDA/EMA and regulations, ICH guidances, and other guidances, as relevant
• Assist in regulatory intelligence assessments related to assigned programs, as needed
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Desired Skills:

• Proficient in written, oral, and interpersonal communications
• Ability to manage complexity and uncertainty
• Ability to work in a small company within a largely virtual environment; small biotech/pharma experience
• Embraces company core values

Education & Experience:

• BA/BS degree required in a biological/physical sciences or pharmacy. Advanced degree in related discipline preferred.
• 2-3+ years of regulatory affairs experience; 5 years in the biotech / pharmaceutical industry
• Familiarity with US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices
• Experience in oncology preferred

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