Shire Regulatory Affairs Specialist, Korea in Seoul, South Korea

Summary

Responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for products and communication of regulatory requirements in support of licensing of the products.

Under supervision, ensure product quality and conformance to regulations and internal quality policies.

Description

  • Compile and submit, in a timely manner, regulatory documents according to regulations

  • Ensures that all inspection and test procedures are properly completed and documented

  • Prepare, review, and approve labeling and SOP’s. Supervise lower level team members on complex issues.

  • Provide regulatory advice to project teams.

  • Respond to regulatory authorities questions within the specified deadlines

  • Maintain regulatory files in a format consistent with requirements· Develop and initiate regulatory project plans

  • Manage regulatory activities relating to specific portfolio of products/projects (product owner)

  • Maintain and update existing regulatory authorizations

  • Represent Regulatory Affairs in project teams

  • Review promotional material for compliance with local and global regulations

  • Product release after GMP document review.

  • Implement and monitor the artwork management process.

  • Participate in identifying solution to meet regulatory system requirements

  • Maintain awareness of regulatory requirements and evaluate potential impact to internal operations.

  • Adhere to all company policies and applicable SOPs

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.