
Hybrid Regulatory Affairs Associate Selfcare (Lisbon, Lisboa, PT, N/A) bei Reckitt
Reckitt · Lisbon, · Hybrid
- Professional
- Optionales Büro in Lisbon
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
Ensure Regulatory leadership for the delivery and execution of new initiatives ensuring timely delivery/submission and launch milestones as well as portfolio compliance according to relevant legislation.
Your responsibilities
- Ensure the registration and regulatory compliance of Reckitt's marketed products with relevant Portuguese and European regulatory requirements to bring competitive advantage to our brands.
- Documentation Management System.
- Monitoring and interpreting local regulatory issues and trends that will impact the marketability of company products.
- Regulatory and Safety Advice.
- Representing Company interests with local government agencies, industry associations for the purpose of negotiating legislation, regulations and guidelines.
- Help with GDP compliance including customs documentation, batch release or any other activity related to GDP compliance of our portfolio.
- Local release of medicines and products under this role. Interfacing and representing company interests with local government agencies and industry associations when required.
- Supervise that the vigilance process works properly and be one of the points of contract for suppoting the Local Drug Safety Officer, Global Vigilance Teams, QPPV and Customer Relations Teams.
The experience we're looking for
- Bachelor's degree focused on pharmaceutical sciences.
- At least 2 years working experience in a regulatory affairs function in Healthcare, Pharmaceutical, industry.
- Portuguese and English proficiency.
- Strong understanding of regulatory legislation and GMP requirements relevant to a regulated product.
- Results oriented, tenacious and resilient.
- Leadership and interpersonal skills capable of building strong working relationships.
- Strong commercial understanding of business isuues/opportunities.