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Regulatory Affairs Supervisor - P&G Health Brazil
Are you passionate about making sure every detail has been met? Do you love crafting business strategies?
At this job, you will help deliver our brands advance to market and will support procedures to ensure the compliance of all product and retail packages. All of our roles provide competitive wages as well as the opportunity to engage and grow in your profession across growing categories.
=== AS A REGULATORY AFFAIR SUPERVISOR, YOU WILL BE RESPONSIBLE FOR: ===
- Develop and execute registration strategies to deliver winning initiatives in P&G Health Brazil.
- Prepare and compile appropriate high quality regulatory dossiers (registration and post-approval) and responses to Health Authority (BoH) questions in accordance with in-house standards.
- Closely work with RA (regulatory affairs) regional team members to ensure completion of tasks within agreed timelines.
- Work in line with RA Manager to develop and implement regulatory strategies that enable delivery a pipeline of product innovation to meet regulatory requirements.
- Provide support for maintenance work on post-approval changes for authorised products, preparing the necessary processes and documents for these submissions.
- Develop, review and approve artworks and marketing promotional material following the local rules and procedures.
- Evaluate change control requests and report to Regional team.
- Perform reviews and due diligences of products dossiers considering the current and applicable laws in place in the country in order to identify and mitigate any compliance gap.
- Ensure maintenance of all registered and marketed products in compliance with national regulatory requirements.
- Assist RA Manager in development of registration strategies and assessments.
- Lead regulatory compliance of formulas, artwork and product in collaboration with regional regulatory or category managers.
- Collaborate with multi-functional teams to resolve technical challenges or issues raised by external stakeholders.Operationalize regulatory compliance work to enable improved efficiency and effectiveness.
- Negotiate regulatory matters with authorities and trade associations to timely ensure commercialization of consumer products.
- Upload/maintain registration documentation and update associated electronic databases, in line with in-house procedures.
- Maintain information/materials complete in share point, common drivers, portal and other channels as per internal procedures for easy access to RA teams properly.
P&G serves consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Bonux®, Gillette®, Head & Shoulders®, Downy®, Naturella®, Olay®, Oral-B®, Pampers®, Pantene®, Pantene®, Vicks® The P&G community includes operations in approximately 70 countries and more than 100 thousand employees worldwide. Please visit www.pg.com for the latest news and information on our company and its brands.
We´re committed to providing equal opportunities in employment. We value diversity and we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status or disability status.
WHAT WE OFFER YOU:
- Responsibilities from Day 1 – You will start working for key categories or brands from the beginning.
- Recognized state of the Research & Development skills – We will constantly help you improve your research knowledge and management abilities.
- You'll receive continuous coaching & mentorship– We are passionate about our work. We will make sure you receive both formal training and as regular mentorship from your manager and others.
- You'll be part of a dynamic and respectful work environment – We live our Purpose, Values, and Principles daily. We value every individual and encourage initiatives promoting agility and work/life balance.
- You'll join an international team with regional responsibilities.
- Flexible work arrangements.
- Competitive salary and benefits program
QUALIFICATIONS REQUIRED FOR THIS ROLE:
- Degree in Pharmacy;
- Approximately 8-10 years in Pharmaceutical Regulatory Affairs area, specially working with OTC products.
- Understanding of processes and departments within a pharmaceutical company.
- Are able to work independently, multi-task and perform in a high pressure environment.
- Have excellent problem-solving skills and uses data to connect multiple ideas and develop solutions.
- Attention to detail.
- Good communication skills.
- Able to work under pressure and to tight timelines.
- Understanding of pharmaceutical development and life cycle management.
- Effective time and organisation management.
- Time flexibility.
- Computer literacy (Windows Office, SharePoint, I.E.).
- Be able to communicate in English (advanced). Spanish skills is considered as a nice to have.
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