Regulatory Affairs (RA) Specialist (Contract)

Regulatory Affairs (RA) Specialist
(6 months contract)

About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission.

Job Purpose:
To contribute as an integral member of the client organization's Singapore RA team to support all regulatory activities for the client 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:

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 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 (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:

• Bachelor's degree in health-related science, life science, Pharmacy degree desired.
• At least 1 years of experience in regulatory affairs
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of therapeutic products.
• Good understanding of the local regulatory environment, guidelines and processes for product registration. 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