Regulatory Affairs Manager

仕事内容

To drive optimal regulatory outcomes and ensure governance on regulatory activities in Taiwan.

• Make sure the regulatory activities of the company are in compliance with regulations and SOPs.
• Be responsible for regulatory submissions and timely tracking status of the progress, including new product registration, license and manufacturing site certificate maintenances & variations.
• Review documents that pertain to matters such as formulation change, raw material change, etc and conduct assessments.
• Maintain records of tasks and registered product information in the internal regulatory databases.
• Liaise with commercial and supply chain functions and give regulatory support
• Gather and share regulatory intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.
  

Education

• Bachelor of Science or related discipline
• Bachelor of Pharmacy degree or above (advantageous)
  

Certifications or Designations

• Qualified Pharmacist with CME credits in Taiwan (advantageous)
  

Experience

• A minimum of 5 years RA experience in pharmaceutical industry (ethical products) in Taiwan
  

Knowledge And Skills

• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.
• Ability to develop strategies and solutions within the regulatory context within the scope of global requirements and available resources.
• Strong initiation and organization skills
• Outstanding written and oral communication and negotiation skills.
• Knowledge, experience and track record of delivering successful regulatory outcomes for regulatory activities
• Fluent English and Chinese
• IT skills