Requisition ID: 1805686681W
The Senior Regulatory Affairs Specialist MD is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices and pharmaceutical products under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications and line extensions, including the opportunity for placement of clinical trials within the country in collaboration with MD&D.
1. The Senior Regulatory Affairs Specialist MD will be a member of the local regulatory affairs department within Johnson & Johnson Medical, with responsibility to support the regulatory aspects of the assigned product portfolio/s
2. Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
3. Maintain departmental and source company databases of regulatory approvals
4. Complete copy and labeling review as required
5. Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Singapore and request the documentation required for registration submissions
6. Build constructive relationships with the local health authority and executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
7. Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
8. Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices
9. Participate in discussion groups for the industry association, as required
10. Contribute to RA Team meetings to learn from colleagues, share experiences and best practice
11. Coordinate the release for supply of unapproved medical devices under the Special Access Scheme (SAS)
12. Engage Marketing colleagues to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
13. Manage interactions with stakeholders and distribution centers as required to ensure product supply is not disrupted.
14. Leverages a solid working knowledge of the global regulatory environment, including proposed laws, regulations and guidance, to inform compliant Regulatory strategies to contribute to the development of business strategies.
15. Act as auditee/ SME for regulatory issues in internal and external audits.
• Bachelor’s degree or equivalent in Pharmacy or related discipline;
• Familiarity with the regulatory systems and product registration requirements in Country;
• Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and or Registration dossiers) is desirable;
• Excellent verbal and written communication skills – proficiency in written and oral English is required;
• Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;
• Demonstrated ability to handle multiple projects;
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required;
• Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;
• Proactive team player, able to take charge and follow-through.