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美國, 臨床及註冊 | 2021-09-01

Regulatory Affairs Scientist-Strategy (Senior Manager to Director)

Primary Functions

  • The mission of Hutchison MediPharma (US) Inc. Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline products through approval in US and EU
  • In this position, the Regulatory Affairs Scientist-Strategy (Senior Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies
  • Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU.

Major Responsibilities and Duties

  • Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries;
  • Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators;
  • Liason with US FDA, EU and other regulatory authorities as assigned;
  • Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU;
  • Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development;
  • Ensure compilation of electronic submissions according to current health authority standards;
  • Provide regulatory oversight by developing and implementing SOP’s;
  • Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects

Qualifications and Education Requirements

  • BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR
  • Advanced degree, e.g. PhD, PharmD and 2 years industry experience
  • Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals
  • NDA or BLA filing experience a plus
  • Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines
  • Good leadership, organization, problem-solving & communication skills
  • Excellent written and oral communication skills
  • Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process
  • Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus
  • Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus
  • Knowledge of EU regulatory regulations a plus
  • Ability to manage priorities and workflow, managing multiple projects and meeting deadlines
  • Acute attention to detail
  • Good judgement with the ability to make timely and sound decisions

 

If interested, please forward your resume to kellier@hutch-med.com.