Senior Associate Regulatory Specialist

Kenvue•Jersey City, NJ

2d•Hybrid

About The Position

Kenvue is currently recruiting for a: Senior Associate Regulatory Specialist What we do At Kenvue, 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. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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. The Senior Associate Regulatory Specialist is responsible for ensuring compliance with regulatory agency regulations, preparing responses to regulatory agencies' questions, gathering necessary information for submissions, and providing solutions to problems of moderate scope and complexity:

Requirements

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

Nice To Haves

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

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