RA Manager, Intelligence & Policy

About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

• Be responsible for information collection/consolidated information summary, and interfacing within China/Taiwan/Hongkong and global Regulatory Intelligence.
• Be responsible for impact assessment via leveraging team expertise, and information dissemination.
• Work on the platform of R&D-based Pharmaceutical Association Committee or independently to provide positive influence on the decision making of key regulatory policy.
• Establish and oversee a regulatory stakeholder mapping plan to ensure optimal communication, dialogue and advocacy for policy and product-related issues.
• Provide comprehensive regulatory insights on the regulatory environment and trends to help BI identify or capture the business opportunity.
  

• Education:
• BSc degree or or above (e.g. MBA, MSc) in pharmaceutics or the related major
• Competencies & Experience:
• The individual must have a very good overview of the current regulatory environment, in particular how the regulations apply to the regulatory activities of the company.
• At least 8 years working experience in a regulatory affairs environment and a profound knowledge of Health Authority divisions, personnel and procedural concepts
• Good knowledge of drug regulations and guidance documents on drug development, new drug applications, variations and line extensions
• Good communication skills
• Good English skills, oral and written
• At least 8-year experience in drug regulatory affairs or related work experience.