Senior Manager, Development RA Group - Pharmaceutical Company

勤務地 東京都
雇用形態 正社員
給与 ¥10000000.00 - ¥14000000.00 (年収)
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 薬事,
お問合せ Hidetoshi Sato
JOB ID JO-2305-481341

MANDATORY

  • Applicants must have permission to work in Japan
  • Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑Foreign business ☑English language required

[Position]
Senior Manager, Development RA Group

[Company Description]
Global Insurance Company

[Position Summary]

  • The Japan Regulatory Leader (or This position) is primarily responsible for the development of Japan regulatory strategy to advance the Company's portfolio of development pipeline candidates and life cycle management of marketed products in collaboration with the Global Regulatory Leader (GRL).
  • The individual will provide strategic input and ensure operational execution of Japan submission activities.
  • The individual will be responsible to interface directly with the PMDA/MHLW as the primary contact for the company for assigned programs.

[Responsibilities]

  • Develop Japan regulatory strategy for the assigned project(s) and ensure their efficient and effective execution for pipeline and lifecycle assets.
  • Collaborate with GRL to align with the global regulatory strategy.
  • Lead the planning and implementation of regional regulatory activities (e.g., new drug application, PMDA consultation, orphan drug designation and clinical trial notification).
  • Oversee regulatory document preparation to be complied with regional requirements.
  • Ensure appropriate labelling content and contribute to post-approval regulatory processes Accountable for the Japan regulatory strategy/position to regional/global stakeholders and health agencies.
  • Interpret the regulations and communication of any health agency feedback and assess the impact on the project.
  • Evaluate regulatory risk and recommend mitigation strategies.
  • Collaborate with external partners to align and execute regulatory strategies in support of compound development.

[Requirements]

  • A minimum of Bachelor of Science, post-graduate degree in life sciences or related field is desirable.
  • A minimum of 10 (7) years of experience in pharmaceutical industry.
  • A minimum of 5 years of drug development experience in regulatory affairs of pharmaceutical industry (oncology experience preferred).
  • Experiences of strategic planning and cross functional management in new drug application and other regional regulatory activities.
  • Comprehensive knowledge of regulations as well as new drug development processes.
  • Verbal and written communication skills in Japanese and English.

[Location]
Tokyo

[Salary]
10 million JPY - 14 million JPY (Experiences and skills will be considered)

[Welfare]
Social insurance

[Holidays]
Full 2 holiday week system (Sat/Sun), National holidays, New year's holiday, Annual Leave

[Selection Process]
Application screening and several interviews are scheduled.

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2305-481341
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Strategy / Planning, Management