Regulatory Affairs Associate
About the company
Orion Group Life Sciences are currently recruiting a Regulatory Affairs Associate on behalf of our multinational biopharmaceutical client based in Queenstown, Singapore on an initial 12 month contract with possibility to extend.
Your tasks
- Support JAPAC Regulatory Affairs affiliates and Global Regulatory Affairs in Marketing Authorisation (MA) and lifecycle management activities for assigned projects.
- Manage relationships with internal and external regulatory and cross-functional stakeholders, including direct and indirect interaction with regulatory agencies.
- Implement regulatory strategies for assigned projects across JAPAC countries, aligned with regional commercial priorities and Global Regulatory Affairs.
- Partner with commercial, market access and medical teams to ensure business needs are met.
- Represent JAPAC Regulatory Affairs in cross-functional teams, providing regulatory requirements and strategic input for product registrations.
- Assess scientific data against JAPAC national and regional regulatory and clinical requirements, identifying gaps and developing mitigation strategies.
- Manage clinical trial, new drug applications and product lifecycle activities to ensure regulatory requirements are met.
- Monitor and communicate changes in regulatory requirements that may affect marketing authorisation applications and timelines.
- Identify regulatory risks and develop solutions to minimise their impact on project strategies and timelines.
- Contribute to process optimisation initiatives within JAPAC and global regulatory teams.
- Represent JAPAC Regulatory Affairs in global and regional meetings, including teleconferences outside normal office hours.
Requirements
- Bachelor's degree in Pharmacy, Pharmacology, Biology or a related discipline.
- Minimum 5 years' experience in Regulatory Affairs.
- In-depth knowledge of regulatory requirements across JAPAC countries preferred.
- Understanding of JAPAC cultures and business practices would be beneficial.
- Proven interpersonal, communication and negotiation skills.
- Ability to communicate strategic and tactical regulatory matters to management and stakeholders.
- Strong problem-solving skills and ability to work effectively with cross-functional teams.
- Ability to identify regulatory risks and develop appropriate mitigation strategies.