Regulatory Affairs (RA) Specialist
(1 year 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.
Role Overview:
To contribute as an integral member of the client Regulatory Affairs (RA) team to support all regulatory activities for the client'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.
Key Responsibilities:
Regulatory Strategy
- Prepares submission dossiers for post-approval variations within agreed timelines.
- Maintains general knowledge of latest regulatory requirements.
- Establish and maintain good working relationships 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 verifies 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 (SCM) on shipment matters when required.
- Collaborates with 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 when required.
- Collaborates with RA Business & Operational Excellence (BoE) on obtaining the required for regulatory submission.
Requirements:
- Diploma or Bachelor's degree in health-related science, life science or pharmaceutical science
- At least 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.
- Able to manage data, statistics and report writing.
- Good interpersonal, organizational and problem solving skills
- Excellent verbal and written communication skills.
Reg No: R22104540
EA License no: 94C3609
