Associate Director, Regulatory Affairs
New
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Summit Therapeutics Inc.Biopharmaceutical oncology
Remote (US)Full-TimeDirector
Salary$168,000 — $198,000 USD
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Job Details
- Languages
- Strong written, oral communications in English; knowledge of Chinese is desirable.
- Experience
- A minimum of 5+ years of experience in regulatory affairs
- Required Skills
- Microsoft Office
Requirements
- Hold a BA/BS degree in Biotechnology, Biological Sciences, or a related field; a graduate degree such as an MS, PhD, or PharmD is a plus.
- Have at least 5 years of regulatory affairs experience in the (bio)pharmaceutical industry.
- Know US FDA and international pharmaceutical guidance and regulations, the drug development process, and industry-standard practices.
- Have experience working in complex, matrix environments with multiple stakeholders.
- Have experience interfacing with government regulatory agencies and health authorities.
- Bring a strong clinical foundation and understanding of the relevant disease landscape.
- Demonstrate strong written and oral communication skills in English.
- Have strong negotiation skills and the ability to work under pressure, act proactively, and build cross-functional consensus.
- Be able to organize, prioritize, and delegate assigned projects with attention to detail.
- Be proficient with the standard MS Office suite, including Word and Excel.
- Experience with CROs managing ex-US CTAs and ex-US health authority interactions is preferred.
- Experience with electronic document management systems and document review tools is desirable; knowledge of Chinese is desirable.
Responsibilities
- Provide scientific and biological regulatory guidance to project teams and clinical study sub-teams.
- Develop and implement global regulatory strategies for ivonescimab, considering scientific aspects, applicable requirements, and risks.
- Manage molecule- and study-level regulatory activities, including CTA and IND submissions and review of investigator document packages and FDA submissions.
- Interpret regulatory requirements for project teams in the context of clinical studies.
- Coordinate agency-query responses, track regulatory commitments, and maintain relationships with regulatory agencies and subject matter experts.
- Own scientific and regulatory content and strategy for BLA and MAA filings.
- Manage regulatory timelines, dossiers, queries, and the consistency and completeness of submissions.
- Lead FDA meeting preparation and health authority meetings, including meeting packages and responses to agency queries.
- Oversee regulatory and ethics submission records, approvals, and document archiving across clinical studies.
- Coordinate submission review and sign-off, and train new employees on regulatory processes and submission procedures.
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