The posting
Senior Regulatory Affairs (RA) Specialist (12 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 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:
- Plans regulatory strategy and supports New Drugs Application (NDA) and supplemental submissions within agreed timelines
- Perform regulatory assessments and prepare submission dossiers for variations
- Timely communication with Regional/Global RA on regulatory strategies, submissions and approvals
- Build effective working relationship with the health authority and follow-up closely on submissions and approvals
- Maintains general knowledge of latest local regulatory requirements
- Supports impact assessments such 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.
- Support both the investigation of regulatory compliance gaps and the development and implementation of gap remediation plans
- Successful interaction with health authority to achieve business objectives
- Ensures compliance with internal local and global policies, SOPs and regulatory systems
- Ensures compliance with local regulations and relevant guidances, including but not limited to:
- labelling and packaging - licence renewals - certificate applications - unregistered product applications - controlled drug/psychotropic applications
- Supports the preparation and interview during inspection(s) and audit(s) where required.
- Coordinate with printers and manufacturers on packaging material changes.
- Identify gaps in processes and support the implementation of process improvements
- Appointed as a responsible person to enable importation and distribution of products, as required
- Monitors and prepares regular reports on key activities, including regulatory projects
- Collect and process information from stakeholders to support the agreed regulatory strategies
Cross functional collaborations and stakeholder management:
- Ensure compliance of promotional and non-promotional materials with local regulatory requirements, trade association guidance and internal corporate policies
- Collaborates and supports discussions with Commercial, Medical and Value Access in alignment with regulatory strategy to review upcoming pipeline and ensure successful launch of new products and new indications
- Collaborates with Medical to facilitate importation and supply of unregistered therapeutic products for patient’s use through alternative import routes (e.g. Named Patient, etc.) and support local health authority submission
- Collaborates and supports discussions with Quality Assurance (QA) on quality matters (e.g. deviations, audits and inspections, serious breaches, market actions, etc.) and reporting to health authorities, when applicable
- Collaborates and supports discussions with Supply Chain Management (SCM) on supply-related matters (e.g. management of out-of-stock situations, communication with life-cycle implementation (LCI) experts, etc.) and support local health authority submission, when applicable
- Collaborates with both QA and SCM on launch and post-approval implementation, including timely communication of registration approvals
- Collaborates and supports discussions with Patient Safety (PS) on safety matters (e.g. serious audits and inspections, breaches, safety notifications, etc.) and reporting to health authorities, when applicable
- Collaborates with Site Monitoring & Management (SMM) on clinical trial matters (e.g. clinical trial-related submissions including serious breaches and urgent safety measures, audits and inspections, etc.) and support other health authority related communication, when applicable Collaborate with Legal to provide regulatory support (e.g. impact assessment, etc.) on patent and data exclusivity
- Collaborates and supports discussions with Value Access to provide regulatory support on tenders and specification updates (e.g. impact assessment and management of out-of-stock situations, new sites, conversion of stocks, etc.)
Requirements:
- Bachelor’s degree in health-related science, life science, Pharmacy degree desired.
- At least 3 years of experience in regulatory affairs
- 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.
- 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
