Lowongan kerja Regulatory Compliance Assistant Manager – HPC

Kirim Lamaran. Belum punya akun? Daftar sekarang.

Lowongan Kerja
Lokasi Loker

Main accountabilities:

Handling Expertise & Acquisition of Rules or HEAR:

  • Act as the FPOC for compliance expertise in their area of responsibility
  • Design, maintain and improve a network of internal (I/A) and external regulatory experts
  • Collect and assess relevant regulation/legislation from authorities and trade associations in their own area of expertise
  • Co-ordinate collection and assessment of relevant regulation/legislation from authorities and trade associations by external/internal experts
  • Define local regulatory requirements and convert them into standardised rules, then input into automation/externalisation tools
  • Maintain regulatory rules and knowledge for automation/externalisation tools
  • Review and assess relevant regulation phrases defined by GRAM/RRAM in automation tools
  • Monitor and assess the impact of regulatory change, and work collaboratively with CPC Division
  • Manage the budget for external experts
  • Assess the compliance capability and quality of third parties (PSO, 3PM)

Dossier Submission and Defence:

  • Operate compliance business processes where a local presence is mandatory (e.g. registrations), or handles the execution via 3P
  • Act as Dossier Submission & Defence (DSD) role; Deliver documents to authorities and follow-up in their own country
  • Act as FPOC for product audits by authorities in their own country
  • Act as FPOC for Post-launch compliance challenges by authorities in their own country

Engagement with Global Product Compliance teams:

  • Consult with the GPC teams (division/capability) to adapt global ways of working, and receive expertise guidance for compliance issues or improvement.
  • Inform GPC teams (division/capability) and CPC on regulatory changes
  • Input and content governance for processes and tools
  • Leverage global engagement to enable regional implementation or improvement of automated/outsourced processes for the Cluster in collaboration withthe GPC Division/Automation/Process team
  • Leverage relevant global expertise and knowledge where required for authority audits or other challenges within the cluster

Interfaces:

  • Internal
  • MCOs, CPC teams, GPC Division, GPC Capability teams, Local RA Managers/members, Trio team
    External
  • Authorities, Professional Service Outsourcing partners, Business Process Outsourcing partners, Regulatory Data providers, Third Party Manufacturers

PERSONAL PROFILE:

  • Bachelor/Master degree in Science or equivalent degree
  • Good communication skills in English, both written and verbal
  • Experience and expertise in local regulations/legislations (one or more categories)
  • Ability to liaise with other functions in Unilever and with Authorities
  • Fully operational in interpreting complex regulations
  • Working knowledge in advocacy and negotiation skills;
  • Capable to pro-actively engage with and manage stakeholders
  • Attention to details, very-well organised, and logical/systematic thinking