Johnson & Johnson Careers
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Regulatory Affairs Associate
Requisition ID: 1805630961W
- Registration of new products and/or presentations and renewal of existing ones
- Maintenance of established products.
- Liaising between the LOCs & the global teams (Labeling, Quality, CMC, etc).
- Update & maintenance of regulatory databases & systems.
- Align with J&J guidelines and local laws & regulations.
- Submit products files to MOH either for new registration or renewal and ensure that filing & submission meet local requirements & company objectives.
- Handle the preparation, review, submission and follow-up of regulatory files in the proper format and in compliance with local regulations.
- You should be involved in all aspects of the application to take the product to market.
- Execute regulatory plans and handle timelines to achieve the stated goals.
- Ensure that important local regulations are properly communicated to the different partners internally & externally.
- Respond to inquiries from the different HAs.
- Maintain archiving of correspondences and other records of all filings and interactions with regulatory authorities.
- Update regulatory databases, tracking tables & information systems.
- Develop & maintain relationships with Health Authorities & other relevant organizations.
- Maintain current knowledge of existing as well as emerging regulations, standards and guiding documents.
- Provide regulatory support to all company functions upon request.
- Align with local laws & HCC guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).
- Ensure that all regulatory activities are conducted in compliance with significant laws & regulations as well as J&J guidelines.
- Confident communication and presentation skills, both verbal and written.
- Shown ability to handle multiple assignments.
- Strong interpersonal skills to take care of sensitive and occasionally contentious issues.
- Ability to work cross -functional to resolve complex issues.
- Dream to work as part of an effective, cohesive group.
- Highly organized.
Directly reports to: Senior Regulatory Affairs Manager
Functional relationships Internally: All
External: Local Health Authorities
Bachelor's Degree from Medical related field.
Past experience in RA field.
Comprehensive knowledge of regulatory requirements, MOH regulations & guidelines.
Strong knowledge base and skill set in science.
Excellent relationships with MOH Officials within Health Authorities & other relevant organizations.
Janssen Pharmaceutica N.V. (7555)