Job Information
J&J Family of Companies Regulatory Specialist, Global Regulatory Strategic Compliance (GRSC) in National Capital, Philippines
Regulatory Specialist, Global Regulatory Strategic Compliance (GRSC) - 2407021206W
Description
Kenvue is currently recruiting for:
Regulatory Specialist, Global Regulatory Strategic Compliance (GRSC)
The position is a global role partnering with colleagues situated in various regions and sites.
The position requires a highly motivated candidate possessing sufficient regulatory experience, who can effectively lead & support processes and innovation projects.
The candidate is required to interact with global, regional, and local market colleagues to accomplish the plans within responsibility.
The candidate will also be responsible for compliance metrics within scope.
This position reports to a Senior Manager, GRSC, based in Paranaque, Philippines.
Who We Are
At Kenvue (https://kenvue.sharepoint.com/teams/PXEB-EB-assets/Shared Documents/2. Final Assets from Corporate Brand Design/kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSONS and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage and have brilliant opportunities waiting for you! Join us in shaping our futureand yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
What You Will Do
Principal Responsibilities:
Support Senior Manager, GRSC:
Provide support to the Senior Manager, GRSC as delegated or needed within areas of responsibility.
Handle other job scopes as required to drive and support Kenvue consumer business.
Cultivate Compliance Culture:
- Promote and cultivate a compliance culture focused on right-first-time practices with consumer protection in mind.
CAPA-INV/NC Governance:
Act as a global functional resource for CAPA-INV/NC governance.
Lead the CAPA-INV Management Team (CMT) Core Group.
Maintain and improve the CMT forum.
Oversee end-to-end monitoring of RA-owned and RA-impacting CAPA-INV.
Partner with Quality and Pharmacovigilance (PV) colleagues.
Represent or designate roles in global cross-functional forums.
Serve as an author and functional area approver.
Audit Readiness:
Act as a global functional resource for audit readiness.
Build and maintain audit groups networks.
Maintain and improve the GRA audit preparation and outcome tracker.
Enhance preparation reminders to boost internal and external compliance.
Pharmacovigilance System Master File (PSMF):
Handle GRA monthly contribution to Appendix 2 - Self-Identified PV-related deviations.
Drive process improvement opportunities within the PSMF.
Innovation Hub
- Enhance data analytics capabilities by developing and optimizing functional metrics and dashboards.
Qualifications
What We Are Looking For
Required Qualifications
Bachelors degree in any science field (Pharmacy, Biochemistry etc.) or any relevant field.
Minimum of 3-5 years in a regulatory affair or change management role.
Extensive experience in regulatory affairs within the consumer healthcare industry.
Proven track record in end-to-end monitoring of RA-owned and RA-impacting CAPA-INV (Corrective and Preventive Actions - Investigation/Nonconformance).
Strong background in quality assurance and pharmacovigilance.
Experience partnering with Quality and PV colleagues to ensure compliance and consumer protection.
Demonstrated ability to lead and manage CAPA-INV Management Team (CMT) Core Group.
Proven experience as a global functional resource, providing support across regions.
Proven experience in developing and optimizing functional metrics and dashboards to enhance data analytics capabilities
Expertise in CAPA-INV/NC governance.
Experience maintaining and improving CMT forums and processes.
Experience handling monthly contributions to Pharmacovigilance System Master File (PSMF) and managing PV-related deviations.
Whats In It For You
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
Learning & Development Opportunities
Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Asia Pacific-Philippines-National Capital-Paranaque
Job Function Regulatory Affairs
Req ID: 2407021206W