Regulatory Operations Senior Manager
About The Position
The Senior Manager of Regulatory Operations will lead global regulatory processes across KISS’s expanding product portfolio—including cosmetics, OTC, medical devices, feminine care, and emerging categories. This role oversees end-to-end regulatory documentation, international product registrations (EU CPNP, UK SCPN, Canada, and other markets), CPSR/PIF management, SDS and WERCS oversight, and compliance readiness for new launches. The position will strengthen RA operational excellence by building scalable workflows, guiding technical reviews, managing cross-functional communication, and ensuring timely regulatory approvals to support global market expansion. The Regulatory Operations Senior Manager is responsible for leading and managing all regulatory activities across KISS’s expanding global product portfolio, including Cosmetics, OTC, Medical Devices, Drug products, Hair & Chemical products, Feminine Care, and emerging categories. This role will oversee day-to-day RA operations, establish processes, manage team workflow, and ensure timely regulatory submissions across US, EU/UK, Canada, and other markets. The Senior Manager will act as the primary coordinator for RA activities while collaborating closely with Legal/Compliance, R&D, Product Development, Operations, and Sales teams. All final regulatory interpretations, risk evaluations, and product launch approval decisions remain under Director of Legal. The Senior Manager ensures smooth execution, documentation, and cross-functional alignment.
Requirements
- Bachelor’s degree in Chemistry, Biology or related scientific field.
- 7–10 years of Regulatory Affairs experience within cosmetics, OTC, or medical device industry.
- Strong operational leadership experience; prior management of RA specialists preferred.
- Hands-on experience with US/EU/Canada registrations, CPSR/PIF, SDS, WERCS, and global compliance documentation.
- Deep understanding of claims review, ingredient restrictions, labeling rules, and regulatory risk frameworks.
Nice To Haves
- Experience managing multiple global categories simultaneously.
- Familiarity with online marketplace compliance, Amazon/Walmart regulatory requirements, and K-beauty products.
- Experience interacting with external labs, testing vendors, and certification bodies.
- Strong project management skills (PMP or RA certification a plus).
- Korean language ability (preferred but not required).
Responsibilities
- Regulatory Operations & Workflow Management Lead daily operational management of the RA team (3+ members), including task assignment, timeline management, and review coordination.
- Build standardized workflows, checklists, SOPs, and documentation systems for RA processes.
- Implement structured review stages (working-level review → Director of Legal escalation).
- Ensure consistent, organized communication with internal stakeholders and external partners.
- Global Regulatory Submission & Compliance Oversee US, EU, UK, Canada, and APAC market registrations and regulatory submissions for all product categories.
- Coordinate SDS management, EU/UK cosmetic notifications (CPNP and UK SCPN), CPSR/PIF preparation and review, WERCS registrations, international regulatory documentation packages, Certificates of Conformity (CoC) requests, and other regulatory filings.
- Manage and maintain regulatory databases, filing systems, and version control.
- Review marketing and packaging claims for compliance with FDA/FTC guidance
- Product Category Expansion Support Support the regulatory onboarding of new business categories: OTC Monograph Drug products (Sunscreen, Acne, Dandruff, Hair regrowth, etc.) Medical Device (Class I/II) Drug products (e.g., minoxidil, salicylic acid) Feminine products, personal hygiene products Skin care & chemical categories Provide operational leadership to ensure all cross-functional teams have clear regulatory requirements and timelines.
- Regulatory Intelligence & Cross-Functional Support Monitor regulatory updates across US/EU/CA and prepare internal summaries.
- Assist Director of Legal in evaluating new regulations/monitoring regulatory updates and determining company impact.
- Coordinate with R&D and product development teams on formula changes, ingredient restrictions, claims review, and packaging compliance.
- Issue Escalation & Communication Management Serve as first-line RA contact for internal teams, but escalate all risk, interpretation, and compliance matters to Director of Legal.
- Ensure the RA team does not unilaterally block launches or make regulatory interpretations without Legal review.
- Ensure all major RA issues are documented and reported weekly to Director of Legal.
- Maintain a collaborative and transparent team culture with high communication standards.
Benefits
- Premium Medical Insurance Coverage
- 401(k) Savings Plan
- Paid Time Off (PTO) based on seniority
- Paid Holidays
- Annual Bonus Plan
- Onsite Employee Fitness Center with Indoor Racquetball Court and Yoga Room
- Summer Fridays
- Complimentary Gourmet Breakfast, Lunch, and Dinner
- Relocation Support for New Hires
- Work Anniversary Recognitions
- Congratulatory & Condolence Gifts
- Employee Referral Bonus Program
- License/Certification Reimbursements
- Corporate Employee Discounts
- Visa Sponsorships (100% paid by the company) i.e., New H-1B, H-1B Transfer, O-1, and Green Card
- Commuter Support (Shuttle Bus Program and EZPass Support)
- Vehicle Perks
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
251-500 employees
