Regulatory Affairs Associate

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.

Major Responsibilities

• 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.

Education & Experience

• 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.