Regulatory Affairs Strategist

1 month ago


London, Greater London, United Kingdom AstraZeneca Taiwan Full time

AstraZeneca Taiwan seeks an experienced Regulatory Affairs Strategist to play a pivotal role in identifying and executing regulatory strategies that support commercial objectives.

Job Description

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with UK regulations.
  • Manage the regulatory process, including planning and execution of workload for defined product responsibilities.
  • Negotiate with regulatory agencies to provide rapid approvals with competitive labeling.
  • Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety, and supply chain functions.
  • Ensure timely submission and approval of license applications and maintenance activities.
  • Adhere to UK regulatory requirements and maintain appropriate standards and policies.
  • Liaise with Operations to manage pack changes and ensure labeling compliance.
  • Provide regulatory input into promotional copy approval processes.
Requirements

Essential Skills and Qualifications:

  • Significant experience working within a Regulatory Affairs organization in a UK-based or Global Pharmaceutical company.
  • Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role.
  • Experience in creating and delivering regulatory strategies.
  • Postgraduate qualification.
Benefits

This Role Offers:

  • Competitive salary: NT$4,500,000 - NT$6,000,000 per annum, depending on experience.
  • Bonus benefits.
About AstraZeneca Taiwan

AstraZeneca is a leading biopharmaceutical company dedicated to pushing the boundaries of science to deliver life-changing medicines. Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Strategist and be part of a team that makes a difference in people's lives.



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