About SpringWorks Therapeutics

SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.

About the Role:

The Senior Director of Regulatory Affairs CMC is responsible for leading the Company's Regulatory CMC function to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products. They will provide the organization with the strategic and operational leadership required to ensure Regulatory CMC compliance with global (both US and ex-US) regulations and submission requirement for clinical studies and commercial supply!

This Regulatory Affairs CMC leader is responsible for strategy decisions and risk mitigations for regulatory submission issues related to CMC. They will ensure effective collaborations and partnership with Quality and technical functions within the Company, as well as external partners and suppliers. They will also supports the growth of the organization as development assets advance through the clinical research process and are commercialized for distribution.

Responsibilities Include:

  • Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, DMFs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submissions and marketing applications to the FDA, and if required international regulatory authorities), and ensure appropriate follow-up correspondence.
  • Leads the hands-on preparation and coordination in preparation and authorship of regulatory documents in clinical programs, CMC, quality, process improvement and laboratory control.
  • Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities.
  • Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
  • Along with the CMO, serves as interface with reviewers from FDA and other health authorities.
  • Provide regulatory CMC expertise during due diligence and in support of new projects.
  • Coordinates activities for meetings with FDA and other regulatory authorities, leads negotiations and interactions with regulatory authorities.
  • Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations.
  • Coordinates with cross functional teams to define contributions to submissions.
  • Maintains current knowledge of regulations and guidelines (FDA, ICH and other as required).
  • Ensures compliance with health authority regulations.
  • Define global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
  • Reviews clinical study protocols, clinical study reports, investigator brochures and CMC reports.
  • Interprets pre-clinical and clinical results and develop those into sound regulatory positions and strategy.
  • Develops and maintains cooperative relationships with external vendors and regulatory health authorities.
  • Communicate CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to project team and appropriate management levels within and outside of Regulatory CMC.
  • Perform other duties and responsibilities as assigned

About You: Required Education, Skills, and Experience

  • Education: Bachelors in scientific field or equivalent
  • 12+ years experience in regulatory CMC
  • 8+ years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of both large and small molecule drugs preferred. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems, highly desirable.
  • Deep expertise and understanding of the CMC disciplines, technical development and manufacturing, quality and supply chain and experience working on CMC Teams.
  • Proven ability to prepare and submit documents to FDA and globally, such as, Investigational New Drug (INDs), and New Drug Applications, (NDAs ), Marketing Authorizations Application (MAA), Clinical Trial Application (CTA) or Investigational Medical Product Dossier (IMPDs).
  • Must have direct experience working with FDA and other international HAs, with confidence and persuasion to meet desired outcomes locally and nationally.
  • Solid experience and knowledge of US regulations and ICH Q guidance, principles, concepts, industry practices and standards.
  • Deep expertise and understanding of the CMC disciplines, technical development and manufacturing, quality and supply chain and experience working on CMC Teams.
  • International CMC regulatory knowledge and experience (preferred, but not required)
  • Experience leading and driving successful regulatory submissions, with first-hand knowledge of and experience interacting with FDA and European authorities at centralized or national level.
  • Excellent regulatory writing skills and ability to critically review regulatory documents.
  • Solid experience and knowledge of US regulations and ICH Q guidance, principles, concepts, industry practices and standards.
  • Strong attention to detail with an ability to understand the broader picture and priorities.
  • Excellent interpersonal skills with ability to lead, interact with, focus, mediate / resolve conflict, and drive consensus among individuals from a variety of cultures and disciplines.
  • Demonstrated ability to lead cross-functional teams.
  • Effective working individually and aligning within a multi-disciplinary team, as well as with external partners and vendors.
  • This position must be able to work East Coast hours
  • Ability to travel occasionally (>15%)

Are you a SpringWorker?

How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?

At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients.   We work hard, we care even harder and we’re in it together.  We are looking for ambitious, smart, and hardworking colleagues to join our growing team.                                  

SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.

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