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Senior Regulatory Executive

3 months ago


Jakarta, Jakarta, Indonesia Shiseido Full time

MAIN PURPOSE

This incumbent is responsible for managing the company's regulatory scope to protect, grow and support the company's business and reputation in the cosmetics industry. In this role, the incumbent is responsible for regulatory monitoring and lead or support the implementation of new regulations. The role will also require the incumbent be responsible for the successful product registrations with BPOM to support the Go-to-Market needs of the portfolio of brands in the company. The incumbent will also be in-charge Regulatory compliance, review of the claims and communication and provide Regulatory intelligence to the company.

KEY RESPONSIBILITIES

  • Build and maintain external relationships with relevant local bodies and cosmetic associations.
  • Responsible for regulatory monitoring, updating and preparing the company on regulatory changes to be in compliant with regulatory requirements.
  • Actively engage internal stakeholders on claims and communications to ensure no violation of Ad Claims
  • Lead or supporting implementation new upcoming regulations
  • Preparing and submit mandatory reports to BPOM
  • Product notification registration with BPOM and securing approval in a timely manner through close and proactive monitoring and follow-up with BPOM or MOH (Authority)
  • Acting as a liaison officer and have a good relationship with Authority
  • Responsible for preparing and compiling Product Information File (PIF) file
  • Liaise with APAC Regulatory Department in supporting the company in regulatory compliance requirements.
  • Collaborate with internal stakeholders in preparation of product notification registration

REQUIREMENTS

  • Degree in Bachelor's Phramaceutical, Chemistry or Biology (preferrabley having Professional Certification Pharmacist)
  • Experience in product registration minimal 3-5 years in Cosmetics Industry with engagement with BPOM.
  • Proficient in written and spoken English
  • Good in Microsoft Office especially in Excel and PowerPoints
  • Good presentation skill
  • Good knowledge and ability to understand formulas, ingredients and contents of the
  • Strong leadership skill and able to lead diverse stakeholder (regulator, local and regional team) in implementation of regulatory requirements
  • Strong project management skill and ability to prioritize and multitasking.
  • Strong collaborator with internal and external network
  • Resilient and positive growth mindset
  • Strong communication and interpersonal skills are required to engage authorities, regional and global counterparts.
  • Proactive and detail oriented
  • Good ability to handle multiple projects and priorities