Kenvue · 4 days ago
Senior Associate Regulatory Specialist
Summit, NJ
Full-time
Hybrid
Mid, Senior Level
$105K/yr - $149K/yr
4+ years expKenvue is a company dedicated to everyday care, known for its iconic brands such as NEUTROGENA® and TYLENOL®. They are seeking a Senior Associate Regulatory Specialist responsible for ensuring compliance with regulatory agency regulations, leading regulatory submissions, and providing guidance on regulatory strategies for product development.
LifestylePersonal HealthWellness
Responsibilities
Lead regulatory submissions for new product approvals and post-approval changes
Develop and maintain regulatory strategies to ensure compliance with global regulations
Provide regulatory guidance to cross-functional teams on product development and lifecycle management
Conduct regulatory intelligence to stay abreast of changes in regulations and guidelines
Collaborate with regulatory agencies to address inquiries and resolve issues
Lead and manage regulatory activities for a diverse portfolio of products
Collaborate with cross-functional teams to develop and implement regulatory strategies
Review and approve promotional materials to ensure compliance with regulatory guidelines
Provide guidance and support on regulatory processes such as Drug Listing and Periodic Safety Reporting
Develop and maintain reporting schedules for regulatory submissions
Present status updates on regulatory activities to key stakeholders
Participate in joint company/trade association initiatives and regulatory agency meetings
Drive continuous improvement in Regulatory Affairs processes and best practices
Ensure quality and compliance in all regulatory actions
Qualification
Required
Bachelor's degree in a scientific discipline or related field
4-6 years of experience in regulatory affairs within the pharmaceutical industry
Strong knowledge of global regulatory requirements and guidelines
Proficiency in Word, Excel, PowerPoint, Email, and Internet applications
Strong attention to detail and problem-solving skills
Preferred
Experience with regulatory processes such as IDMP and safety reporting
Excellent communication and interpersonal skills
Excellent interpersonal skills with a collaborative approach
Ability to work effectively in a fast-paced and dynamic environment
Ability to multitask and deliver high-quality work under pressure
Effective communication and stakeholder management skills
Benefits
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
Company
Kenvue
Kenvue is a consumer health company that delivers personal health solutions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$3.65BKey Investors
Third PointStarboard Value
2025-11-03Acquired
2025-04-25Post Ipo Equity
2024-10-21Post Ipo Equity
Leadership Team
Kirk Perry
Chief Executive Officer and Director at Kenvue
Andrew Stanleick
President, Skin Health & Beauty, North America and EMEA at Kenvue
Recent News
Hindu Business Line
2026-01-22
Benzinga.com
2026-01-20
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