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Associate Director, Regulatory Affairs
Kura Oncology Boston, MA
$138k-186k (estimate)
Full Time | Ambulatory Healthcare Services 5 Months Ago
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Kura Oncology is Hiring an Associate Director, Regulatory Affairs Near Boston, MA

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Essential Job Functions

Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will be responsible for the operational implementation of regulatory strategies to support global development of Kura’s oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications.

To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our patients drives decisions and actions.

  • Evaluate applications for completeness and compliance with applicable regulations. Lead the maintenance of regulatory applications (IND/CTA, NDA) to ensure compliance with applicable regulations (e.g., amendments, annual reports, safety reports). Draft and manage regulatory documents and other submissions, as assigned.
  • Provide regulatory support and guidance to cross-functional project teams, as assigned.
  • Conduct regulatory review of submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with business objectives, regulations, guidelines, and quality standards.
  • Collaborate with internal and external stakeholders to ensure adequate planning and execution of submissions. Work with Regulatory Operations to create submission content plans and ensure timely preparation and submission of preclinical, clinical, and/or technical data in the required eCTD format.
  • Ensure correspondence and submissions are appropriately archived.
  • Perform regulatory research and intelligence to continually inform project teams of the evolving regulatory landscape and to identify changes and potential strategic implications.
  • As appropriate, support interactions with regulatory authorities, including developing meeting requests and briefing documents, and assist in the development of overall regulatory strategies.

Job Specifications:

  • Minimum bachelor’s degree in a science discipline or related discipline
  • 8 years pharmaceutical/biotechnology industry experience, 5 years of regulatory and/or related experience
  • Experience with planning and managing IND/CTA submissions.
  • Oncology, orphan-drug, NDA and commercial regulatory affairs experience a plus.
  • Strong understanding of US and EU regulatory landscape
  • Demonstrated ability to think critically and analyze scientific information while paying close attention to detail.
  • Demonstrates ownership of results within (and beyond) area of responsibility
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
  • The ability to influence and negotiate professionally at various levels within the project team and with external partners.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ambulatory Healthcare Services

SALARY

$138k-186k (estimate)

POST DATE

10/21/2022

EXPIRATION DATE

11/09/2023

WEBSITE

kuraoncology.com

HEADQUARTERS

BOSTON, MA

SIZE

50 - 100

FOUNDED

2014

REVENUE

<$5M

INDUSTRY

Ambulatory Healthcare Services

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