- Clementi West Region (Singapore) Singapore
ORION PROJECT SERVICES PTE. LTD. Hiring! Full Time Regulatory Affairs Associate in West Region (Singapore), Earn up to SGD 7,500 - Ricebowl
Regulatory Affairs Associate
ORION PROJECT SERVICES PTE. LTD.
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Job Description
Responsibilities
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.
Orion Group provides specialist life science recruitment support across pharmaceuticals, biotechnology, medical devices, agri science, and R&D organisations worldwide. Across a variety of disciplines, we connect businesses with skilled scientific, engineering, manufacturing, quality, and technical professionals who help drive innovation in highly regulated industries.
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.
Orion Group provides specialist life science recruitment support across pharmaceuticals, biotechnology, medical devices, agri science, and R&D organisations worldwide. Across a variety of disciplines, we connect businesses with skilled scientific, engineering, manufacturing, quality, and technical professionals who help drive innovation in highly regulated industries.
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