Listed on the Catalyst board of the Singapore Exchange (SGX), Hyphens Group has a direct presence in Singapore (HQ), Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering additional jurisdictions like Hong Kong, Myanmar, Brunei, Cambodia, Oman and Bangladesh, South Korea and China. Hyphens Pharma is looking for a Regional RA Executive to join the team.
Job Description
Product Registration (Regional):
- Spearheading the registration and maintenance of marketing authorizations for health products (Therapeutic Products, Medical Devices, Cosmetic Products and Health Supplements) across multiple regions.
- Preparation and managing of registration files in accordance to the requirements of health authorities in multiple regions to secure approval on time according to regional launch plans agreed by management.
- Support Head of Regulatory Affairs in conducting regulatory due diligence
Regulatory Compliance (Regional):
- Complying with regional renewal timelines, staying atop of all registration and establishment licenses that keeps changing in different countries.
- Maintain marketing authorizations by submitting variations and other necessary updates in a timely manner to avoid disruption in-market supply in multiple regions.
- Maintain regulatory-related databases.
- Assist with the creation and maintenance of GDP & PV-related SOPs for the region.
- Support regional GDP & PV audits.
Pharmacovigilance (Regional):
- Manage adverse event and product complaint reporting across multiple regions.
- Ensure adherence to reporting timelines with Health Authorities and Partners for adverse events and product complaints across different regions.
- Coordinate with local regulatory affairs personnel and principals for all pharmacovigilance activities, including reviewing and submission of safety reports, PSUR requests, etc.
- Offer pharmacovigilance training to regional teams.
- Help with the regional tracking and reconciliation of adverse events and product complaints.
- Maintain pharmacovigilance-related databases regionally.
Requirements
- Licensed pharmacist with 2+ years of relevant working experience preferred, with experience in handling regulatory affairs across multiple regions.
- Good attention to detail.
- Strong interpersonal and communication skills with a positive attitude and results-oriented approach.
- Proven ability to manage multiple regulatory requirements and stakeholders across different regions
- Experience in handling regulatory with Thai FDA is a plus
