Head of Regulatory Affairs (RE-33904623)

Location: Tokyo, Japan
Salary: ¥22000000 - ¥24000000 per annum + competitive
Job Type: Permanent
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<MAIN PURPOSE OF ROLE>

  1. Manages teams within the Regulatory Affairs Sub-Function
  2. Focus is on policy, strategy implementation and control rather than development
  3. Handles short-term operational/tactical responsibilities

<About the Company>

Leading global medical device company that develops innovative technology, tools and treatment options to help people worldwide

<MAIN RESPONSIBILITIES>

  1. As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
  2. Interacts with regulatory agency to expedite approval of pending registration
  3. Serves as regulatory liaison throughout product lifecycle
  4. Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC)
  5. Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products
  6. Serves as regulatory representative to marketing, research teams and regulatory agencies
  7. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations

​<QUALIFICATIONS >
Education

Associates Degree (± 13 years)


Experience/Background

Minimum 7 years in related fields

Real is part of the larger SThree K.K group

To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com

Award winner of:

Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018

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