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Associate Director Regulatory Affairs

Company: Frontage Lab
Location: Exton
Posted on: June 13, 2021

Job Description:

Associate Director, Regulatory Affairs, Tigermed, US Based

Home Based

Job Purpose:

  • To establish and maintain regulatory team in the United StatesTo perform project supervision activities timely and effectively to ensure the running of the responsible Regulatory Team goes smoothly.
  • To participate or lead regulatory project related to US FDA filing.

Responsibilities:

  • Be responsible for the management of operation on the responsible Regulatory Team, achieve the team business objectives.
  • Be responsible for building and maintaining the good relationship with important RA-related business clients and various regulatory authorities esp. US FDA.
  • Be responsible for the coordination and supervision of the registration project, to provide the regulatory guidance, support in RA team if necessary.
  • Be responsible for supporting the company's business development department in determining the business development strategies and participating important RA-related BD activities if necessary.
  • Be responsible for working with HR Dept. for RA-related staffs training, keeping and developing RA talents.
  • Be responsible for providing support to other functional departments on view of regulatory affairs.

Minimum Qualifications:

  • Academic / Major -Bachelor's degree or above; Major in pharmaceutical, medical, biological, life science, English, Japanese and other related discipline.
  • Professional Skills-have full knowledge of regulations in relevant countries or regions.
  • Working Experience-Minimum 7+ years of R&D working experience or RA experience or R&D plus RA experience.
  • Language ability-Fluent English and Chinese to effectively communicate with sponsor about the regulatory needs in the United States.
  • Computer Literacy
  • Well verse in MS Excel, Word and PowerPoint and general computer skills.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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Keywords: Frontage Lab, Wilmington , Associate Director Regulatory Affairs, Other , Exton, Delaware

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