Job Purpose
To contribute as an integral member to Singapore RA team to support all regulatory activities. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.
Regulatory Strategy
• Prepares submission dossiers for post-approval variations within agreed timelines.
• Maintains general knowledge of latest regulatory requirements.
• Establish and maintain good working relationship with internal and external stakeholders.
• Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
• Determine regulatory relevance and perform variation assessments.
Management of Regulatory operations
• Develop and maintain regulatory database(s) as required.
• Maintain and update regulatory files and records as required.
• Ensures compliance with local regulations, corporate policies, and procedures.
• Prepares and verify monthly reports in addition to providing timely updates to relevant stakeholders.
• Receive, gather, assess, and process information received from assigned stakeholders.
• Provide administrative support where required.
Collaboration with cross-functional teams
• Support process improvements and implementation of best practices.
• Collaborates with Supply Chain Management Team on shipment matters when required.
• Collaborates with Quality Assurance (QA) Team on Quality matters (e.g. investigation of deviations and reporting them to relevant health authorities, when applicable), and Patient Safety (PS) on safety communication when required.
• Collaborates with RA Business & Operational Excellence on obtaining the required for regulatory submission.
Key Requirements
• Degree/Polytechnic Diploma, preferably in the Sciences (Pharmacy, Life Sciences, Biological Sciences etc)
• 1 year of experience in regulatory affairs or related work experience.
• Good knowledge and understanding of pharmaceutical & scientific processes.
• Good understanding of the regulatory environment, guidelines and processes for product registration.
• Attention to detail
• Ability to work with data and basic regulatory SOPs (learning agility and ability to learn independently/on the role will be a big plus)
• Takes ownership of tasks and strong ability to collaborate with team members
Ideal Background
Education (minimum/desirable):
BSc in health-related science, life science, Pharmacy degree desired
Languages:
English - fluent in speaking and writing.
We regret that only shortlisted applicants will be notified.
