Regulatory Manager Portugal
Location: Porto Salvo
About Us:
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.
At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.
Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission to bring health in your hands at www.opella.com.
About the Role: Reporting to the CHC Regulatory Affairs WE HEAD, the Regulatory Affairs Manager PT is responsible for leading/ support the local CHC Regulatory team, is responsible of preparation, submission and followup of applications, ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products.
Key Responsibilities:
Portfolio Management:
Prepare or manage the preparation of marketing authorisation applications, to the highest possible standards within the agreed timeframe for submitting to the regulatory authorities.
Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and take action, to secure regulatory approval where necessary.
Ensure that the internal databases for the products in its portfolio are constantly up to date, compendia and repertories, filing, ...
Oversee the creation of packaging in accordance with regulations and internal guidelines on the subject.
Champion the review and approve promotional and non-promotional materials ensuring their competitive position and compliance with local regulations, code of conduct and internal guidelines.
Regulatory Compliance:
Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.
Ensure local implementation of GRA mandatory SOPs and training
What You’ll Bring:
Have language proficiencies in English (both written and verbal).
Knowledge of local (PT) and international regulatory affairs regulation (MIN 5 years)
Knowledge of CHC regulatory affairs (medicines, food supplements, medical devices), including promotional material (MIN 3 years)
Recognized expert in working in matrix teams
Ability to implement operational regulatory excellence
Excellent communication in Portuguese & English language
Good understanding of the consumer healthcare and pharmaceutical industry
Expert knowledge of consumer healthcare regulations and requirements
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
Www.opella.com/en/careers
