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Director, Regulatory Affairs

Role Summary

Reporting to the VP, Regulatory Affairs, the Director of Regulatory Affairs is responsible leading the overall regulatory strategy for assigned Turning Point Therapeutics programs, focusing on the development and commercialization of the molecule and to achieve the program and corporate goals. The Director will be fully responsible for the development of effective regulatory strategies and leading the execution of those strategies to achieve commercial status including the development of the companion diagnostic.

Role Responsibilities

  • Develop the regulatory strategy and position to achieve the approvals of assigned regulatory submissions and filings globally.
  • Develop strategies to reduce regulatory risks associated with regulatory applications and work closely with cross-functional teams on risk mitigation strategies.
  • Ensure Regulatory Milestones are met to support regulatory approval strategies and overall business goals of the company.
  • Lead and provide direction for effective execution of the developed regulatory strategies including FDA meetings and responses to health authority questions.
  • Defines the content and directs the organization in preparing high quality and effective regulatory submissions.
  • Act as the primary lead in management of regulatory activities for assigned projects
  • Manage the assigned program(s) in a manner that blends the organizational needs with corporate goals.
  • Provide budget and resource planning initiatives for assigned regulatory activities
  • Work in a multi-disciplinary team effectively.
  • Assure compliance with U.S. and international regulations.
  • Exhibit strong organizational leadership and values to influence the success and future direction of Turning Point Therapeutics.

Qualifications

  • BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline is required; an advanced degree (Masters, PhD, RAC certification) is preferred; (an equivalent combination of education and experience may be considered).
  • At least 10+ years of Regulatory Affairs in-depth regulatory experience in a biopharmaceutical company involved with clinical development, manufacturing, testing and distributing ethical pharmaceutical products with at least two years in a management role.
  • Ability to work in a dynamic environment with a high degree of flexibility.
  • Independent management of complex projects.
  • Companion Diagnostic experience is desired.
  • Alliance or co-development partnership experience is a plus.
  • Demonstrated leadership participation with U.S. and international submissions, a working knowledge of FDA/EMEA regulations, the regulators, the approval process, and an excellent track record in building effective relationships with regulatory authorities.
  • Advanced knowledge and utilization of regulations and guidance’s.
  • Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the Company.
  • A strong record of successful U.S. submissions for drugs which include INDs, NDAs/BLAs, MAAs; Annual Reports, and Amendments, and submission experience in oncology desired.
  • Excellent communication skills a must.

EEO & Employment Eligibility

Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Turning Point Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer. of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

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