Johnson & Johnson Careers
Senior Regulatory Affairs Specialist
Requisition ID: 1905774366W
- The Senior Regulatory Affairs Specialist 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
- Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans
- Provide guidance to the junior regulatory colleagues as necessary
- Maintain departmental and source company databases of regulatory approvals
- Complete copy and labeling review as required
- Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Malaysia and request the documentation required for registration submissions
- 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.
- Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
- Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices
- Participate in discussion groups for the industry association or health authority, as required
- Coordinate the release for supply for unapproved products under Special Access intended for personal use, demonstration, education, clinical research, custom-made, special access medical devices
- Engage Marketing colleagues and other stakeholders to strategise new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
- Manage interactions with stakeholders and distribution centers as required to ensure product supply is not disrupted.
- 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
- Bachelor's degree or equivalent in Biomedical engineering, Life science or related discipline;
- Minimum 3 years working experience in Medical device industry in Malaysia
- Familiarity with the regulatory systems and medical device registration requirements in Malaysia;
- 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.
Johnson & Johnson Sdn. Bhd. (8275)