Regulatory Affairs Strategist
1 month ago
AstraZeneca Taiwan seeks an experienced Regulatory Affairs Strategist to play a pivotal role in identifying and executing regulatory strategies that support commercial objectives.
Job DescriptionKey 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.
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.
This Role Offers:
- Competitive salary: NT$4,500,000 - NT$6,000,000 per annum, depending on experience.
- Bonus benefits.
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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