Description
Kenvue is currently recruiting for:
Regulatory Affairs Specialist
This position reports into the Regulatory Affairs Manager CZ/SK/HU and is based in Prague, Czech Republic.
Who We Are
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. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.

What You Will Do
The Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics and consumer commodity products marketed by JNTL Consumer Health (Czech Republic) s.r.o./JNTL Consumer Health (Slovakia) s.r.o. in Czech Republic and Slovakia.

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, as well as cooperation with business in development of claim strategy, signing off promotional materials (in CZ only) and activities related to the above products and timely initiation, coordination and approval of packaging material changes for medicinal products (CZ and SK).

Responsibilities

• Regulatory Strategy

• Regulatory Compliance

• Regulatory intelligence

• Financial:

• Qualified Person:

Qualifications
What We Are Looking For
Required Qualifications

• Relevant Bachelor's Degree or higher

• 4+yrs related regulatory experience

• Preferably experience in GDP for medicinal products

• Knowledge of consumer healthcare environment and product development

• Understanding of processes and departments within a healthcare company

• Effective time and organization management

• 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

What’s In It For You
Employee Benefits:

• 5 weeks of vacation and 3 sick days

• Hybrid model of working / home office

• Pension Insurance

• Meal vouchers, Pluxee benefit cafeteria, Company products with discount

• Language courses contribution

• Referral award

• Public transportation allowance

• Bonus based on company policy

Office Facilities:

• Nice area with restaurants with metro station 300 m from office

• Modern office with coffee and fruits, focus rooms

Health and Wellness Benefits:

• On-site gym and massages

• Global wellbeing reimbursement, Long term illness contribution, Accident, Life, and disability insurance

• Multisport card

• Parental leave and early returning parents program

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Czechia-Prague-Walterovo Namesti

Job Function Regulatory Affairs