Job Opportunities API

Regulatory Affairs Responsible, External Manufacturing API • Location: Budapest, Hungary You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Regulatory Affairs Responsible, External Manufacturing API, you’ll bring your expertise, leadership, and drive to ensure reliable supply, strengthen strategic partnerships, and support the delivery of trusted self-care products worldwide. About the Role: As a Regulatory Affairs Responsible, you play a key role in supporting regulatory compliance and lifecycle management activities across Opella's External Manufacturing Active Pharmaceutical Ingredients (API) network. Acting as a CMC expert for the assigned portfolio, you will ensure the maintenance of regulatory dossiers, support supply continuity, and contribute to the successful execution of regulatory strategies throughout the product lifecycle. · Ensure regulatory management of Change Control for the active · Ingredients of the assigned portfolio. · Ensure management of regulatory submissions for the active ingredients of the assigned portfolio. · Contribute to projects to register new API sourcing, as part of securing EM API activities • Provide support for customer requests for regulatory aspects • Participate in the maintenance of the quality system Main responsibilities · Lead the preparation, review and optimization of CMC regulatory dossiers to support global submissions and lifecycle management · Coordinate internal and external stakeholders involved in CMC documentation and ensure consistency and quality of submissions · Define and drive regulatory strategies for product changes, ensuring timely approvals across multiple markets · Assess regulatory impact of manufacturing or process changes and actively participate in change control activities · Ensure alignment between CMC dossiers and manufacturing practices at API manufacturers, maintaining compliance with global regulations · Support interactions with Health Authorities, including preparation of responses and regulatory documentation · Act as a key regulatory interface across global and local teams, supporting product launches and business opportunities About you · Proven experience in CMC writing and/or Regulatory Affairs within the pharmaceutical industry · Experience in a GMP environment (Quality, Manufacturing, Development, or QC), with strong exposure to compliance topics · Strong communication skills, with the ability to collaborate effectively across cross-functional teams · Ability to manage multiple priorities and timelines in a fast-paced environment · High level of organisation, attention to detail, and problem-solving mindset · Self-motivated, proactive, and able to work independently · Solid knowledge of global regulatory requirements (EU, FDA, ICH, China) · Familiarity with Veeva Vault RIM and/or Veeva Vault Quality is a plus · Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field · Fluency in English (written and spoken) Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds. This is more than the next step in your career, it’s a chance to lead a critical part of Opella’s global supply network and help ensure millions of consumers have access to trusted self-care products. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella. 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 is 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 are our 100+ loved brands, our 11,000-strong global team, 13 best-in-class manufacturing sites, and 4 specialised science and innovation development centres. 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. As a globally certified B Corp company, we are active players in the journey towards healthier people and a healthier planet. Learn more at www.opella.com LI-HYBRID