Associate director Work, Jobs in Fleet, Ham (with Salaries)

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Senior Regulatory Affairs Specialist

Kenvue -
Reading

Apply Now

Job details

Benefits

Annual leave

Qualifications

Stakeholder collaboration
Internal department liaison
English
Bachelor's degree
Organisational skills
Project schedule tracking
Multidisciplinary collaboration
Networking
Cross-functional collaboration
Communication skills
Project progress tracking
Time management

Full job description

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.

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.

Apply Now

Refine Your Search

associate director jobs in fleet, ham

Senior Regulatory Affairs Specialist

Associate Director - Environmental, Health and Safety (EHS)

Manager, Marketing Analytics

Account Director (Life Science)

EAP Program Associate

Senior Community Nurse

Assistant Manager

Associate Director Bioresources Process Engineering

Religious Life and Belief Lead

Business Development Manager (Higher Education)

Associate Quality and Systems Manager – (Asbestos, Fire & Water)

Consultant in Emergency Medicine

ODG Digital Engagement Associate Manager

Lead Drone Surveyor

Solicitor / Associate 0-5 PQE

Associate Director Bioresources Mechanical Engineering

Associate Director Dams and Reservoirs

ODG Digital Engagement Associate Manager (175001)

Associate Director Coastal Engineering

European Technical Associate Director – Global VAT Compliance and Reporting

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