Beschrijving
Regulatory affairs ensures that a product complies with the national Health Authority (HA) requirements and laws during the life cycle of the product, including:
Lead regulatory strategy plans to support new products in the related TA and provide regulatory expertise cross-functional teams.
Ensure timely regulatory filings and response to HA queries.
Provide RA insights to China compound teams for assigned projects.
Establish good relationship with HA and collaborate with key stakeholders in the local, regional and global organization.
Perform with high quality and compliance.
Collaborate with global, regional, and local product teams to develop and implement registration plan and regulatory strategy.
Kwalificaties
Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
Minimum of 5-8 years regulatory affair experience especially for CGT, Ophthalmology in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred.
Strong oral & written communication skill; Strong leadership capability and ability to work under pressure.
In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.
Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
Proficiency in verbal and written English; good computer skill, good presentation skill.