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

Lisboa***,*** Portugal

About the role

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

This is far more than a traditional regulatory role. You will manage complex European regulatory projects, advise international pharmaceutical companies, develop regulatory strategies and work closely with colleagues across the regenold Group in Germany, the UK, Ireland and Portugal.

As one of our senior regulatory experts, you will have significant autonomy, direct client interaction and the opportunity to influence regulatory strategies throughout the entire product lifecycle. You will contribute to projects involving medicinal products, medical devices, food supplements and cosmetics, while helping strengthen regenold Portugal as one of the entities centres of regulatory excellence.

EU regulatory expertise & strategy

Independent project & lifecycle management

Cross-functional collaboration

Client & health authority interaction

Scientific writing & documentation quality

Where you will make an impact

Strategy & Advisory

• Support national, decentralised, mutual recognition and centralised regulatory procedures throughout the product lifecycle
• Prepare, compile and review regulatory documentation for submissions in Portugal and across Europe
• Support marketing authorisation applications, variations, renewals, transfers and other post-authorisation activities

Project & Submission

• Support communications with national competent authorities, the EMA and international clients
• Monitor regulatory developments and help assess their practical impact on clients and projects
• Contribute to proposal preparation, internal knowledge sharing and client meetings, as appropriate

Team & Collaboration

• Maintain accurate project records, trackers and regulatory databases, ensuring deadlines and commitments are followed
• Collaborate closely with experts in Quality, Pharmacovigilance, CMC, Medical Devices and Market Access to support integrated regulatory solutions Your experience and skills

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• 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 languages are considered an advantage

About regenold

Want to know more about us?

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What we offer

• A permanent position with real ownership from day one
• Varied international projects for pharmaceutical companies worldwide
• A highly experienced multidisciplinary team covering Regulatory Affairs, Quality, Pharmacovigilance, GMP, Medical Devices and Market Access
• Close collaboration with colleagues across all entities of regenold in Germany, Portugal, the UK and Ireland
• Progressive exposure to international clients and health authorities
• Continuous professional development, mentoring and tailored training opportunities
• A flexible working environment with partial hybrid working
• Based in Portugal with occasional international travel
• A long-term career opportunity within a growing international consultancy where your expertise will directly shape our continued expansion

International teams and projects

Flexible working hours