Czech Republic Job Openings
Kenvue
Regulatory Affairs Specialist CZ/SK
Prague
November 6, 2024
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
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
o Assists in the coordination, compilation & submission of new drug applications, cosmetics, medical devices, commodities or any similar product to the regulatory agencies within in the territory of Czech Republic and Slovakia.
o Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
o Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
o Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
o Prioritizes, plans and monitors allocated projects against defined timelines
o Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
- Regulatory Compliance
o Ensures that all assigned products comply with local regulatory and quality system requirements.
o Reviews and approves promotional materials for assigned local Kenvue products in Czech Republic.
o Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
o Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained
o Identifies & initiates local process improvement opportunities and manage changes as required
o Assists in the preparation for internal and external audits and inspections in collaboration with others
- Regulatory intelligence
o Cooperation with the health authorities in order to positively affect the regulatory environment
o Identification of potential legislative changes that could affect the portfolio and communicate relevant emerging legislation changes to relevant internal customers
o Active role in interpretation of legislation in Czech Republic and Slovakia
o Implementation of existing legislations in working practices
o Preparation of Impact assessments for all the relevant parties
o Cooperation with the local professional associations or trade associations (if relevant).
o Active participation on European and telecommunications meetings, either group or 1:1 meetings with the CEE Regulatory & Medical Affairs Manager or Regulatory Affairs Manager CZ/SK/HU
- Financial:
o Responsibility to arrange the payment of any relevant regulatory fees related to the above activities, if necessary
o To discuss any Regulatory related cost which do not come from the activities listed with Regulatory Affairs Manager CZ/SK/HU
o Provide reports on the above fees upon request
- Qualified Person:
o Monitors SIFDC legislative regulations, evaluates requirements and ensures their implementation as part of quality assurance
o Checks the up-to-dateness of the required documentation
o Conducts staff training according to the training plan or based on current need
o Organizes inspections of compliance with quality assurance requirements and personally performs inspections as part of planned internal inspections, including record maintenance
o Ensures that internal and external inspections are carried out at regular intervals according to the agreed program and that appropriate corrective measures are taken
o Responsible for the overall supervision of complaint handling
o Checks the progress of administrative release and archiving of release documentation
o Releases suspended products back into the distribution chain after verification and inspection
o On the basis of information from SIFDC/manufacturer/department of health care or his own findings, he is responsible for withdrawing medicinal products.
o Responsible for passing on and evaluating SIFDC information about defects in the quality of medicinal products
o Gives consent to the disposal of medicinal products and archives the disposal protocols
o Responsible for reporting the supply of medicinal products according to the applicable SIFDC instructions
o Controls the system of providing samples of medicinal products
o Communicates with SIFDC, monitors relevant legislation and requirements of SIFDC and implements them
Qualifications
What We Are Looking For
Required Qualifications
What’s In It For You
Employee Benefits:
Office Facilities:
Health and Wellness Benefits:
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.
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
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