Senior Regulatory Affairs Specialist

Posted 5 Days Ago
Be an Early Applicant
27 Locations
Remote
Senior level
eCommerce • Healthtech • Software
The Role
Lead regulatory activities for EMEA medicinal products, preparing and submitting MRP/DCP applications, managing post-approval variations and safety updates, liaising with health authorities, ensuring compliance with local regulatory and quality requirements, supporting audits/inspections, and partnering cross-functionally to meet product lifecycle and regulatory timelines.
Summary Generated by Built In

Kenvue is currently recruiting for a:

Senior Regulatory Affairs 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.

Role reports to:

Senior CMC Manager

Location:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Work Location:

Hybrid

What you will do

The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).

What You Will Do 

  • Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.

  • Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates.

  • Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.

  • Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.

  • Prioritizes, plans and monitors allocated projects against defined timelines

  • Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements

  • Ensures that all assigned products comply with local regulatory and quality system requirements.

  • Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained

  • Identifies & initiates local process improvement opportunities and manage changes as required

  • Assists in the preparation for internal and external audits and inspections in collaboration with others

  • Partner with other critical functions to execute plans to address crises and other sensitive issues

Qualifications : 

  • Required Qualifications

  • Relevant Bachelor's Degree or higher 

  • 6+yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).

  • Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates.

  • Good attention to details.

  • Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.

  • Good interpersonal skills; able to build effective personal networks internally and externally.

  • Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.

  • Strong organizational and time management skills with an ability to work under pressure.

  • Able to work effectively in a multi-cultural, highly matrixed organization

  • Proficiency in English

Desired Qualifications

·         Knowledge of consumer healthcare environment and product development

·         Understanding of processes and departments within a healthcare company

·         Effective time and organisation management

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 

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Skills Required

  • Relevant Bachelor's Degree or higher
  • 6+ years related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP)
  • Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates
  • Collecting and evaluating regulatory requirements for quality, preclinical and clinical data
  • Experience preparing and submitting regulatory submissions for MRP or DCP
  • Good attention to detail
  • Excellent verbal and written communication skills, able to simplify complex regulatory or technical issues
  • Good interpersonal skills and ability to build internal and external networks
  • Collaborative, strong sense of ownership and accountability
  • Strong organizational and time management skills; ability to work under pressure
  • Able to work effectively in a multi-cultural, highly matrixed organization
  • Proficiency in English
  • Knowledge of consumer healthcare environment and product development
  • Understanding of processes and departments within a healthcare company
  • Effective time and organisation management (listed as desired)

Kenvue Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Kenvue and has not been reviewed or approved by Kenvue.

  • Fair & Transparent Compensation Pay is considered decent and competitive for the work performed. Base compensation combined with a solid benefits package supports a generally fair total rewards perception.
  • Healthcare Strength Comprehensive healthcare, life insurance, and disability plans are emphasized. Access to mental health resources and assistance programs further strengthens perceived health protection.
  • Parental & Family Support A global parental leave policy and support for adoption, fertility, and surrogacy are highlighted. These offerings contribute to a family‑friendly and supportive package for diverse families.

Kenvue Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Summit, New Jersey
17,919 Employees
Year Founded: 2023

What We Do

Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands — including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena®, Tylenol® and Zyrtec® — are recommended by health care professionals and can be trusted by consumers who use our products to improve their daily lives. Our team members share a digital-first mindset, with an approach to innovation grounded in deep human insights and work every day to earn a place for our products in consumers’ hearts and homes. At Kenvue, we believe everyday care can not only make people well; it can make them whole. Beware of recruitment scams: https://www.kenvue.com/media/recruitment-scams-alert

Similar Jobs

Rain Logo Rain

Implementation Specialist

Blockchain • Fintech • Payments • Financial Services • Cryptocurrency • Web3 • Infrastructure as a Service (IaaS)
Remote or Hybrid
28 Locations
100 Employees

Rain Logo Rain

Technical Support

Blockchain • Fintech • Payments • Financial Services • Cryptocurrency • Web3 • Infrastructure as a Service (IaaS)
Remote or Hybrid
28 Locations
100 Employees

Deepgram Logo Deepgram

Research Staff, LLMs

Artificial Intelligence • Machine Learning • Natural Language Processing • Software • Conversational AI
In-Office or Remote
49 Locations
150 Employees
150K-250K Annually

Deepgram Logo Deepgram

Account Executive

Artificial Intelligence • Machine Learning • Natural Language Processing • Software • Conversational AI
In-Office or Remote
28 Locations
150 Employees

Similar Companies Hiring

Golden Pet Brands Thumbnail
Digital Media • eCommerce • Information Technology • Marketing Tech • Pet • Retail • Social Media
El Segundo, California
178 Employees
Kepler  Thumbnail
Fintech • Software
New York, New York
6 Employees
Onshore Thumbnail
Artificial Intelligence • Fintech • Software • Financial Services
New York, New York
60 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account