Associate Director, Regulatory Affairs
New
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Summit Therapeutics Inc.Biopharmaceutical Oncology
Remote (US)Full-TimeManager
Salary$168,000 — $198,000 USD
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Job Details
- Languages
- English
- Experience
- Minimum of 5+ years of experience in regulatory affairs
- Required Skills
- MS Office
Requirements
- BA/BS degree in Biotechnology, Biological Sciences, or a related field (graduate degree preferred).
- Minimum 5+ years of experience in regulatory affairs within the biopharmaceutical industry.
- Knowledgeable of US FDA and international pharmaceutical guidance and drug development processes.
- Proven experience working in complex, matrix environments with multiple stakeholders.
- Strong experience interfacing with government regulatory agencies.
- Strong written and oral communication skills in English.
- Ability to work under pressure and proactively build cross-functional consensus.
- Strong clinical foundation and understanding of the oncology disease landscape.
- Experience interacting with CROs and managing ex-US CTAs and health authority interactions is preferred.
- Proficiency with MS Office suite and electronic document management/review systems.
Responsibilities
- Provide regulatory guidance to project teams and key sub-teams at the study level.
- Assess, develop, and implement competitive global regulatory strategies and identify risk mitigation steps.
- Manage study-level regulatory activities including clinical trial application (CTA) and IND submissions.
- Serve as health authority liaison, preparing and leading regulatory meetings and managing query responses.
- Ensure consistency and adherence to standards for all regulatory submissions.
- Oversee labeling meetings and manage the review, finalization, and sign-off processes for submissions.
- Track regulatory timelines, submissions, and document archives.
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