My client is one of the largest names in the biotechnology sector and is looking for an experienced RA Manager to lead RA functions across APAC
- Global Name
- Regional Role (APAC)
- Complete Autonomy
Responsibilities
- Assume responsibility to Oversee regulatory activities in the region
- Develop regulatory strategies in collaboration with regional manufacturing sites, regional marketing, commercial affiliates, and distributor countries
- Ensure timely execution of product registration, major changes, and life cycle management
- Promote awareness of regulatory and customer requirements throughout the organisation;
- Business partner that drives positive financial performance and appropriately partners with external stakeholders.
- Work closely with local RA within the region
- Act as subject matter expert and represent the firm at APAC leadership meetings and Industry forums
- Provide input on regional regulatory environment and policies and identify market trends
Requirements:
- Advanced Degree (Masters/PhD) in Engineering, Biotechnology, Life Sciences or equivalent with at least 12 years' experience in managing regulatory affairs across APAC
- Prior experience with IVD and related instrumentation
- Exceptional knowledge of the regulatory landscape and policies in APAC countries
- Stronghold in Quality and Quality Management Systems
- Ability to communicate effectively across multiple levels of hierarchies
- Excellent trouble shooting and problem-solving skills
- Ability to work in a complex environment
- Travel as required (post-Covid)
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).