At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
We are recruiting to fill the position below:
Job Title: RA and BQ Expert - Nigeria
Requisition ID: 2105942103W Location: Lagos Island, Lagos
Category: Regulatory Affairs
Organization: J & J Company West Africa Limited (8447)
Role Purpose
The successful candidate will act as the local regulatory expert for all therapeutic areas as well as be the Quality Executive for LOC. The jobholder plays a key role in the cross-functional country value teams and will report into the LOC Regulatory Head Near East & SSA / dotted line to LOC Quality Head.
Key Responsibilities
RA Role (50% time):
Act as a RA Expert for the corresponding country, for all Therapeutic Areas (TA)
Support maintenance of marketed products
Liaison and main contact between LOCs and global groups (Therapeutic Areas teams, CMC teams, Labeling teams, Regulatory Quality teams)
Provide regulatory support for daily business and products supply in accordance with J&J guidelines and local laws & regulations
Act as LTR for JNJ Nigeria office
BQ Role (50% time):
Responsible for the GxP (including GMP/GDP) Quality of, and meeting the applicable requirements for, the products and services marketed by the Local Operating Company ‘LOC’/ Cluster (including all named-patient materials NPP/ SPR process and PSP activities)
Supervise compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GxP activities the LOC/ Cluster undertakes
This position is also responsible for the continuous improvement of the GMP/ GDP and Quality system status of the LOC/ Cluster
Oversee the quality and compliance status of all third parties, distributors and other J&J organizations engaged by the LOC/ Cluster for the GxP activities for the LOC/ Cluster
Support the preparation, execution and follow-up for the internal & external inspections for the LOC/ Cluster
Qualifications
Pharmaceutical or scientific university degree
Significant experience (~3-5 years) in Regulatory affairs within the pharmaceutical industry and a proven track record of outstanding approvals
Experience in working in Quality assurance or Market Access is a plus
Reliable, positive, energized, and self-motivating personality, team-player
Strong communication and presentation skills with the ability to convert complex data in simple messages, diplomacy, and interpersonal adaptability
Ability to adapt communication style based on audience and situation
Integrity and transparency
Qualifications
Pharmaceutical or scientific university degree
Significant experience (~3-5 years) in Regulatory affairs within the pharmaceutical industry and a proven track record of outstanding approvals
Experience in working in Quality assurance or Market Access is a plus
Reliable, positive, energized, and self-motivating personality, team-player
Strong communication and presentation skills with the ability to convert complex data in simple messages, diplomacy, and interpersonal adaptability
Ability to adapt communication style based on audience and situation
Integrity and transparency
Fluency in English
Others
Travel requirements:
RA Role ~ 10% to attend global meetings
BQ Role ~ 10% to attend global meetings
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Note: Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.