Regulatory Affairs Associate

ORION PROJECT SERVICES PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Orion Group Life Sciences is seeking a Regulatory Affairs Associate for a multinational biopharma client based in Queenstown, Singapore. The role is a 12-month contract with potential extension, supporting MA and lifecycle activities across JAPAC and collaborating with global teams.

You will manage regulatory strategies, liaise with agencies, and contribute to risk mitigation and process improvements while aligning with regional commercial priorities.

Qualifications

• 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 preferred.
• Understanding of JAPAC cultures and business practices beneficial.
• Proven interpersonal, communication and negotiation skills.
• Ability to communicate strategic and tactical regulatory matters to management and stakeholders.

Responsibilities

• Support JAPAC Regulatory Affairs affiliates and Global Regulatory Affairs in MA and lifecycle management.
• Manage relationships with regulatory stakeholders and agencies.
• Implement regulatory strategies for assigned projects across JAPAC.
• Partner with commercial, market access and medical teams to meet business needs.
• Represent JAPAC Regulatory Affairs in cross-functional teams and meetings.

Skills

Interpersonal skills

Communication

Negotiation

Education

Bachelor's degree in Pharmacy, Pharmacology, Biology or related discipline

Job description

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.