Regulatory Affairs Manager at Opella

Milan, Lombardy, Italy -

Full Time

Start Date

Immediate

Expiry Date

09 May, 26

Salary

0.0

Posted On

08 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Product Maintenance, Regulatory Strategy, Advertising Review, Medicines, Food Supplements, Medical Devices, Regulatory Submissions, Gap Analyses, Compliance, Cross-Functional Collaboration, Interpersonal Skills, Problem-Solving, Innovation, Teamwork, Italian Regulatory Requirements, English Language

Industry

Retail Health and Personal Care Products

Description

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. Why us? At Opella, you will have the opportunity to carry out stimulating and meaningful work, developing a consumer portfolio with passion and creativity. This is your chance to acquire new skills and be part of a culture that challenges the status quo—collaborative and inclusive—where people can express their full potential every day. Job Title: Regulatory Affairs Manager Location: Milan Remote working: 50% Estimated travel time: less than 1% Contract type: Permanent, Full-Time About the job The Regulatory team, part of the Science function, is responsible for product maintenance activities, regulatory strategy, and advertising review for consumers and HCPs across our entire portfolio, which includes medicines (mainly OTC), food supplements, and medical devices. Main Responsibilities The Regulatory Manager is responsible for the maintenance activities of medicinal products (e.g., variations, renewals, etc.) under National/DCP/MRP regulatory procedures, as well as the management and notification of food supplements and medical devices included in the Opella Healthcare Italy portfolio. The role also includes responsibility for the regulatory strategy of the assigned product(s), under the coordination of the Regulatory Coordinator and the supervision of the Science Hub Head. More specifically, the role involves: Preparing regulatory submissions with particular focus on CMC and labelling activities, performing gap analyses to identify the correct regulatory strategy, preparing documentation in response to Regulatory Authorities’ requests, and managing submissions in collaboration with GRA (Global Regulatory Affairs) and other relevant functions (Medical, Pharmacovigilance, Quality, etc.). Managing maintenance activities and ensuring product compliance—for example, timely updates of product artworks, data entry in company tools (Veeva Vault), as well as ensuring compliance and quality of variation dossiers before submission to the Authorities. Managing local regulatory activities in line with internal procedures and national and European regulations, reporting any compliance issues that may arise, and proactively proposing solutions, in alignment with the Regulatory Coordinator. Collaborating cross-functionally within the Science Team in defining and implementing team objectives, and actively participating in cross-functional teams to contribute to business goals. About you: Experience: At least 5 years of experience in Regulatory Affairs within a company, preferably with a Consumer (OTC) portfolio. Education: Degree in scientific disciplines; a Master’s in Regulatory Affairs or equivalent is a preferred qualification. Soft skills: Teamwork and problem-solving attitude; strong interpersonal skills; inclination toward innovation, proposing new solutions, and a “challenger mindset.” Technical skills: Excellent knowledge of Italian and European regulatory requirements. Languages: Fluent in Italian and English. 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 #LI-HYBRID 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 is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. 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 4 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 at www.opella.com. Privacy Notice

Responsibilities

The Regulatory Affairs Manager is responsible for maintaining medicinal products and managing food supplements and medical devices. This includes preparing regulatory submissions, ensuring product compliance, and collaborating with cross-functional teams.