CMCマネージャー - バイオ医薬品企業

Location: Tokyo
Contract Type: Permanent
Salary: ¥7000000.00 - ¥12000000.00 (年収)
Specialization: Life Science (Medical Devices / Pharmaceutical / Chemical / Healthcare / Agriculture / Livestock),
Sub Specialization: Regulatory Affairs,
Contact: Yoshiko Kumakura
Reference: JO-2112-466227

☑Foreign business
☑Japanese language required

[Position]
CMCマネージャー

[Company Description]
外資系バイオ医薬品企業

[Responsibilities]

  • Develop regulatory strategies, plans and timelines, to ensure successful new registrations and effective product maintenances, in line with local business objectives. Manage regulatory submissions process, prepare high quality submission packages and responses to deficiency questions within applicable timelines. Work closely and swiftly with cross-functional and brand teams to update regulatory projects, address critical issues and potential solutions.
  • Provide regulatory advices and supports to business personnel, including tender. Review labeling, promotional and educational materials to ensure compliance. Monitor and forecast regulatory environment periodically, and assess impact to our business.
  • Liaise with drug authorities for insights into current activities and future direction of regulation. Develop and maintain regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient. Develop and manage product registration database to ensure information transmission timely and accurately.
  • Develop, compile and update local SOP on quality management systems, quality accountabilities and working methods. Handle non-medical complaints according to local SOP. Manage cold chain according to global SOP.
  • Conduct management review quarterly. Update package inserts, corresponding overlabels and finished product labels, ensure reviews and approvals in a timely manner. Review and release finished products with proper labeling.
  • Develop and manage product quality database to ensure information transmission timely and accurately. Lead audit activities for QA/RA functions as required. Support PV audit.

[Requirements]

  • Education: Bachelor degree or above in pharmacy or related science. Master degree is preferred.
  • Experience: At least 5 years regulatory affairs experience in pharmaceutical or biotech industry. Working experience with multinational company. Experience with new chemical entities (NCE), biologics and clinical trial application. Familiar with regulatory guidelines and requirements. Project management skill.
  • Adaptability: Try to understand changes. Treat changes and new situations positively. Adjust behavior to deal with changes.
  • Initiative: Respond quickly & being proactive. Implement new ideas or potential solutions without prompting. Take action that goes beyond job requirements in order to achieve objectives.
  • Integrity: Maintain, promote social & ethical norms. Adhere to codes of conduct & ethical principles.
  • Innovation: Generate innovative solutions in work situations. Draw multiple sources for ideas and inspiration. Try different & novel ways to deal with work problems.
  • Teamwork: Share important or relevant information with the team. Listen to & fully involve others in team decisions & actions. Establish & maintain good working relationships with others.
  • Work Standard: Set standards for excellence. Ensure high quality. Take responsibility.

[Language Requirement]

  • Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
  • Work permission in Japan required

[Salary]
7〜12 million JPY
※Experiences and skills will be considered

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-2112-466227
Seniority Level: Mid-Senior level
Job Function: Health Care Provider