Job Information
J&J Family of Companies Regulatory Specialist in National Capital, Philippines
Regulatory Specialist - 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.
This position reports into a Senior Manager Regulatory Affairs and is based at 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, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® 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 future–and yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
What You Will Do
Principal Responsibilities:
Partner with colleagues situated in various regions and sites globally.
Lead and support process and innovation projects with sufficient regulatory experience.
Interact with global, regional, and local market colleagues to accomplish plans within responsibility.
Responsible for compliance metrics within scope.
Support and Business Management:
Provide support to Senior Manager, GRSC as delegated or needed.
Handle other job scopes as required to drive and support Kenvue consumer business.
Compliance Culture:
- Cultivate a compliance culture with a focus on right-first-time and consumer protection.
CAPA-INV/NC Governance:
Lead the CAPA-INV Management Team (CMT) Core Group.
Maintain and improve the CMT forum.
Monitor RA-owned and RA-impacting CAPA-INV end-to-end.
Partner with Quality and Pharmacovigilance (PV) colleagues.
Represent or designate in global cross-function forums.
Possess author and functional area approver roles.
Audit Readiness:
Build and maintain audit groups network.
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 Appendix 2 - Self-Identified PV-related Deviations.
Drive process improvement opportunities in the pharmacovigilance system.
Qualifications
What We Are Looking For
Required Qualifications
Experience in a global role, collaborating with colleagues across various regions and sites. Strong interpersonal skills to interact effectively with global, regional, and local market colleagues.
Bachelor’s degree in any science field (Pharmacy, Biochemistry etc.)
Minimum of 3-5 years in a regulatory affair or change management role.
Extensive regulatory experience, particularly in leading and supporting process and innovation projects.
Proficient in handling compliance metrics and fostering a compliance culture.
Proven track record in cultivating a compliance culture with a focus on consumer protection.
Experience leading CAPA-INV Management Teams and managing related forums.
Expertise in end-to-end monitoring of RA-owned and RA-impacting CAPA-INV.
Competence in partnering with Quality and Pharmacovigilance (PV) colleagues.
Experience building and maintaining audit groups networks.
Proficiency in maintaining and improving GRA Audit Preparation and Outcome trackers.
Ability to manage preparation reminders to boost internal and external compliance.
What’s 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