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Johnson & Johnson (J&J) is one of the largest healthcare firm s in the world and one of the most diversified. Its operations are or ganized into three business segments: pharmaceutical, which generates 47 percent of revenues and 58 percent of operating profits; medical devices and diagnostics, which accounts for 36 percent of revenues an d 31 percent of oper...
Job Description
Johnson & Johnson NEMA is currently recruiting for a Regulatory Affairs Team Lead for their GPH RA team. In this role, you will develop and lead GPH Regulatory Affairs activities, strategy, operations, and compliance activities in African countries' Markets.
You will act as Regulatory Cluster Value team (RA CVT) member and as RA Expert for the corresponding portfolio for small molecules. You will be responsible as liaison and main contact between LOCs and international groups (Therapeutic Areas teams, CMC teams, Labelling teams, and Regulatory Quality teams).
Next to this, you will provide regulatory support for tenders and support daily business and product supply in accordance with J&J guidelines and local laws & regulations as well as ensure optimal compliance to local, regional, and Janssen regulations, to minimize risk for the patient and Janssen business.
Essential duties and responsibilities: Act as Regulatory Cluster Value team (RA CVT) member and as RA Expert for the corresponding Portfolio of Small molecules
Ensure new products registration
Maintenance and follow‐up of marketed products:
Liaison and main contact between LOC and international & external stakeholders
Maintain archiving and appropriate databases and systems:
Compliance Responsibilities
Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects and contracting vendors
Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied when planning projects, developing materials, executing projects and contracting vendors
Daily Business & Product Supply Support
Other features of the job:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Job Qualifications
Candidate profile Education & qualifications
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