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

regenold GmbH; Lisboa; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

regenold GmbH in Portugal seeks an experienced Senior Regulatory Affairs Consultant to lead European regulatory projects, advise international pharma clients and develop regulatory strategies.

You will work with peers across regenold Group in Germany, the UK, Ireland and Portugal, contributing to lifecycle management and a broad product portfolio including medicines, medical devices, dietary supplements and cosmetics.

Qualifications

• 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.

Responsibilities

• 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.
• 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.
• 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.

Skills

Regulatory expertise

Client interaction

Project management

EU pharmaceutical legislation

Analytical thinking

English proficiency

Education

University degree in Pharmacy, Pharmaceutical Sciences or life science

Job description

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 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
• 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

• 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
• Apermanent position with real ownership from day one
• Challenging 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
• Direct exposure to international clients and health authorities
• Continuous professional development 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