Regulatory Affairs Specialist
5 meses atrás
**Regulatory Affairs Specialist**-2307009359W
Description
At **Kenvue**, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.
For our opeations in Portugal, we are currenlty hiring a **regulatory affairs specialist. **You will contribute to business growth ensuring the proper development and monitoring all regulatory processes in the portfolio of the products under responsibility, as well as proactively identify innovations and support their development, licensing and/or promotion in a timely manner, correctly according to law, SOPs in place and properly approved in accordance with the rules of the Company.
**What will you do?**
- Regulatory activities to maintain Marketing Authorizations (MAs) for medicinal products and/or other Authorizations for non-medicinal products (e.g., medical devices, cosmetics, food supplements, and other body care products) in full compliance with National and European regulations and technical standards as well as internal Corporate Standard Operation Procedures (SOPs) and Processes.
- Maintain a deep knowledge of local Portuguese laws on medicinal products, cosmetics, medical devices, food supplements and advertising
- Ensure submission of price changes and annual review of prices to local authorities and support to its implementation in collaboration with the various areas concerned.
- Review and ensure conformity and due approval of product artworks in line with local legislation, local guidelines and internal procedures.
- Technical support on commercial activities to ensure full compliance of advertising and promotional materials to relevant regulations and guidelines, including the communication to national authorities.
- Work in a compliant way and respect the GxP-rules related to the function including: working according to the Global, Regional and Local SOPs; attending internal audits/inspection when needed, support as LRA to local QA in Change Control System, follow of GxP trainings according to the internal GxP trainings plan.
- Contribute to develop and implement dissemination plans consistent with brand strategies, in closely cooperation with medical information team.
- Support business growth by providing valid inputs regarding regulations for business development and keep a close cooperation with brand activation team by ensuring that products and activities/materials reach their commercial potential in Portugal, via Consumers and Healthcare Professionals.
- Support Supply Chain and Quality ensuring that products under responsibility, packaging and others comply with all local regulations.
- Develop a close relationship internal and externa: close working relationship with R&D and regional regulatory affairs EAME skincare, women health, and oral care team in order to implement product launches and/or activities. Strong interaction with local Authorities, developing a strong relationship and represent Company’s interests.
- Work towards the preservation and consolidation of the Company's image among internal and external partners.
**Qualifications**:
- Degree in Pharmaceutical Sciences.
- 3+ years experienced with EU regulations for Medicines, Medical Devices and Cosmetics.
- Fluent written and oral English communication skills
- Digital and Data Fluency: using business metrics, analytics, and internal and external data to generate insights.
- End to end Thinking and Integrated Problem-solving: end to end regulatory thinking to improve innovation and deliver a compliant and integrated solution.
- Business Acumen: understanding the business context in which the organization operates, including business strategy and competition.
- Internal and External collaboration: building and cultivating relationships internally, cross-functionally, and externally. Ability to work with complexity.
- Learning agility and continuous development: learning from experiences and failures and adapting to new situations. Being self-aware, developing self and others’ continuous learning and implementing new skills.
- Adaptability and agility: ability to adjust thinking and behavior to changing situations. Emotional intelligence and resilience to drive and adapt to change.
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 identify, age, national origin, or protected veteran status and will not be discriminated against based on disability.
Primary Locati
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