Senior Regulatory Affairs Consultant (m/f/d)(100%)

Senior Regulatory Affairs Consultant (m/f/d)(100%)

We are looking for an experienced Senior Regulatory AffairsManager to join regenold Portugal and become a key member of ourgrowing international Regulatory Affairs Team.

This is far more than a traditional regulatory role. You will managecomplex European regulatory projects, advise international pharmaceuticalcompanies, develop regulatory strategies and work closely with colleaguesacross the regenold Group in Germany, the UK, Ireland and Portugal.

As one of our senior regulatory experts, you will have significantautonomy, direct client interaction and the opportunity to influence regulatorystrategies throughout the entire product lifecycle. You will contribute toprojects involving medicinal products, medical devices, food supplements andcosmetics, while helping strengthen regenold Portugal as one of the entities centresof regulatory excellence.

EU regulatory expertise & strategy

Cross-functional collaboration

Client & health authority interaction

Where you will make an impact

Strategy & Advisory

• Support national,decentralised, mutual recognition and centralised regulatory proceduresthroughout the product lifecycle
• Prepare, compile and reviewregulatory documentation for submissions in Portugal and across Europe
• Support marketing authorisationapplications, variations, renewals, transfers and other post-authorisationactivities

Project & Submission

• Support communications withnational competent authorities, the EMA and international clients
• Monitor regulatory developments and help assess their practical impact on clients and projects
• Contribute to proposalpreparation, internal knowledge sharing and client meetings, as appropriate
• Maintain accurate projectrecords, trackers and regulatory databases, ensuring deadlines and commitmentsare followed
• Collaborate closely withexperts in Quality, Pharmacovigilance, CMC, Medical Devices and Market Accessto support integrated regulatory solutions

Your experience and skills

• University degree in Pharmacy,Pharmaceutical Sciences or another relevant life science
• At least 7 years of professional experience in European Regulatory Affairs for medicinal products
• Strong knowledge of European regulatory procedures and lifecycle management
• Demonstrated experience managing complex regulatory projects independently
• Excellent understanding of EU pharmaceutical legislation and regulatory requirements
• Experience interacting directly with health authorities and international clients
• Excellent organizational skills with the ability to manage multiple projects simultaneously
• Strong analytical thinking and solution-oriented mindset
• Excellent written and spoken English
• Additional European languagesare considered an advantage
• Apermanent position with real ownership from day one
• Varied international projectsfor pharmaceutical companies worldwide
• A highly experienced multidisciplinary team covering Regulatory Affairs, Quality, Pharmacovigilance, GMP, Medical Devices and Market Access
• Close collaboration withcolleagues across all entities of regenold in Germany, Portugal, the UK andIreland
• Progressive exposure tointernational clients and health authorities
• Continuous professionaldevelopment, mentoring and tailored training opportunities
• A flexible working environmentwith partial hybrid working
• Based in Portugal withoccasional international travel
• A long-term career opportunity within a growing international consultancy where your expertise will directly shape our continued expansion