Regulatory Affairs Associate Selfcare

Reckitt Benckiser

  • Lisboa
  • Permanente
  • Horário completo
  • Há 16 dias
We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.​Research & Development​In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.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 roleEnsure 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.
The skills for successCommercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy.What we offerWith inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.EqualityWe recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

Reckitt Benckiser