Senior regulatory affairs manager Work, Jobs in West Berkshire, Brk (with Salaries)

Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Senior Product Manager, Women's Health - Europe
BD —Winnersh
- £59,100 - £90,150 a year
- Marketing
- English
- Master's degree
Senior Technical Policy Executive
The Horticultural Trades Association —Didcot
- £35,000 - £40,000 a year
- Full-time
- Hybrid work
- CRM software
- Analysis skills
- Presentation skills
- Free parking
- Health & wellbeing programme
Quick apply
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Senior Product Manager – Global Web
Elanco —Hook
- Full-time
- Analysis skills
- Product management
- APIs
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
Quality Engineer
Steris —Swindon
- Full-time
- English
- Maths
- Continuous improvement
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Department for Environment, Food and Rural Affairs —Reading
- £42,665 - £46,765 a year
- Part-time
- Presentation skills
- Leadership
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Senior Regulatory Affairs Specialist

Kenvue -
Reading

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Job details

Benefits

Annual leave

Qualifications

English
Bachelor's degree
Product development
Organisational skills
Communication skills
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

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senior regulatory affairs manager jobs in west berkshire, brk

Senior Regulatory Affairs Specialist

Senior Product Manager, Women's Health - Europe

Senior Technical Policy Executive

Senior Product Manager – Global Web

Local Study Associate Director

Quality Engineer

Senior Commercial Officer - Infrastructure North & South

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