Summit Therapeutics

Summit Therapeutics

Associate Director, Regulatory CMC

Palo Alto, CA (US) · Director

Sponsorship not specified$194k-$199kDetected 58 days ago
ComplianceExcelSupply ChainProcess ImprovementRecruitingClinical TrialsFDA RegulatoryCommunicationCollaborationProblem SolvingCritical ThinkingOrganizational SkillsRegulatory Affairs

About the role

  • The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high-quality global regulatory filings.
  • This role will provide regulatory strategy input, and oversee preparation of regulatory submissions in collaboration with other stakeholders including CMC, Supply Chain and QA.
  • The Associate Director is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders.

Responsibilities

  • Works closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in developing global regulatory strategies and preparing submissions for the approval for assigned products.
  • Manage internal review and approval process for CMC related submissions
  • Manage timelines for assigned projects in alignment with company goals
  • Support in providing interpretation of global CMC regulations and guidelines, to Summit personnel for assigned programs
  • Provide regulatory impact assessment to CMC changes and deviations and plan, prepare and manage any related regulatory submissions as necessary.
  • Maintain up to date knowledge of global regulations and guidances pertaining to CMC issues
  • Planning, development and finalization of high-quality Regulatory CMC documents to meet global regulatory requirements.

Nice to have

  • Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
  • Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Skills

  • 6 or More Years Regulatory CMC experience and/ or related Pharmaceutical industry experience required.
  • Experience in biologics required
  • Thorough and extensive knowledge of FDA and EU regulations required
  • Experience in preparation of CMC sections for regulatory submissions (IND, IMPD, BLA, MAA, Amendments, Supplements etc)
  • A good understanding of IND, CTA, BLA and MAA
  • Proficiency in Mandarin Chinese (spoken and written) is highly desirable
  • Strong computer and database skills
  • Attention to detail, accuracy and
  • Clear and concise oral and written communication skills
  • Excellent organizational skills
  • Critical thinking, problem solving, ability to work
  • Communicate effectively and articulate complex ideas in an easily understandable way

Compensation

  • $194,000 - $199,000 USD
  • Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
  • This may be different in other locations due to differences in the cost of labor.
  • The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
  • Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
  • All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Benefits

  • Coordinate the planning and preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests
  • RA support in interactions with Health Authorities (HA), as
  • Experience, Education and Specialized Knowledge and
  • Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.

Company info

  • At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality.
  • Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Equal opportunity

  • Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.