MNC Pharma - Regulatory Affairs Manager
Transparent and efficiency communication style and company culture
Strong pipeline and new challenges
About Our Client
Our client is one of the top biotech companies globally. The company research based and is middle size in Taiwan with strong pipeline in specialty products. They're currently expanding and have exciting plans for new product launch. A strong RA Manager is urgently in need.
- Work closely with cross-funcitons to fulfill the assignments of regulatory affairs
- Responsible for regulatory activities, including preparing and submitting complex regulatory documents which require interaction with departments outside of Regulatory Affairs, for assigned investigational and/or marketed products, in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
- Is recognized as a knowledgeable resource for Regulatory Advice on specific topics by other departments.
- Liaises with TFDA for assigned products.
- Maintains knowledge of regulatory requirements and communicates changes in regulatory information to project teams and management in a timely manner.
- Initiate local process improvements and contribute to local and /or global process improvements, which have a moderate impact on the Regulatory Affairs function or other departments.
- Plans, schedules and arranges own activities and may direct others in accomplishing objectives.
The Successful Applicant
- 5+ years of experience in Regulatory Affairs or other relevant industry experience preferable
- Degree in a scientific field preferable.
- Business Acumen
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- Must be capable of developing and implementing regulatory strategies, leading teams in preparation of submissions, and influencing colleagues across functions.
- Excellent interpersonal and organizational skills, and ability to work on and/or oversee a number of projects within aggressive timelines.
- Excellent verbal and written communication skills.
What's on Offer
Deep engagement with regional/global with abundant sharing resources and support.
Great autonomy for each individual as the company culture is quite mature and respectful.