Regulatory Affairs (RA) Specialist
(12-month contract)
About the Company:
Our client is a Swiss pharmaceutical based corporation that provides solutions to address the evolving needs of patients worldwide. Their main discoveries are development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.
Job Purpose:
To contribute as an integral member of the organization’s Singapore RA team to support all regulatory activities for the organization’s products. 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.
Primary Responsibilities:
In this role, you will be responsible for all or subset of the key responsibilities below:
Regulatory Strategy
- Prepares submission dossiers for post-approval variations within agreed timelines.
- Maintains knowledge of latest regulatory requirements for therapeutic products.
- Establish and maintain good working relationship with the Health Science Authorities (HSA).
- Acts as primary RA contact for the local Singapore team for the projects assigned.
- Ensures that new regulatory initiatives and changes are shared with the regional/global RA function in a timely manner with critical assessment of potential impact on business for the projects assigned.
- Investigate regulatory compliance gaps with gap remediation plan development and implementation thereafter.
- Perform variation assessments when requested by global RA Franchise teams.
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 monthly project status updates.
- Checks and ensures promotional materials comply with local regulatory requirements and corporate policies where required.
- Supports new drug applications and post-approval variations for (Singapore), or any other portfolio (where necessary).
- Support inspection(s) and audit(s) where required.
Collaboration with cross-functional teams
- Support process improvements and implementation of best practices.
- Collaborates with local Quality Assurance (QA) on Quality matters (e.g. investigation of deviations and reporting them to relevant health authorities, when applicable), and Patient Safety (PS) on safety communication to HSA.
- Collaborates with RA Business & Operational Excellence (BoE) on obtaining the Singapore Certificate of Pharmaceutical products (CPP) for the requesting country
Requirements:
- Bachelor’s degree in health-related science, life science, Pharmacy degree
- At least 1 years of experience in regulatory affairs or related work experience within the pharmaceutical industry.
- Proven track record of preparing and reviewing regulatory documentation, and managing submissions successfully.
- Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of therapeutic products
- Ability to apply knowledge to general regulatory topics for projects assigned
- Computer literacy with knowledge of MS Office applications
- Good interpersonal, organizational, negotiation and problem solving skills
- Excellent verbal and written communication skills
Reg No: R22104540
EA License no: 94C3609
