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

regenold GmbH; Portugal; Hybrid; EUR 26,000 - 40,000; Full time

Job summary

regenold Portugal is seeking a Junior Regulatory Affairs Consultant to join our international Regulatory Affairs team and grow your career within regenold. You will support European regulatory projects, contribute to documentation and strategies, and work closely with teams across regenold in Germany, the UK, Ireland and Portugal.

You will gradually take on increasing responsibility, gain exposure to international clients and regulatory activities across the product lifecycle, and may contribute

Qualifications

• Up to 2 years of professional experience in Regulatory Affairs; internships or academic projects valued.
• Basic knowledge of European regulatory procedures and the medicinal product lifecycle.
• Motivation to learn, take responsibility and develop within a consulting environment.
• Very good written and spoken English; additional European languages are 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.
• Collaborate closely with experts in Quality, Pharmacovigilance, CMC, Medical Devices and Market Access to support integrated regulatory solutions.
• Monitor regulatory developments and help assess their practical impact on clients and projects.
• Maintain accurate project records, trackers and regulatory databases, ensuring deadlines and commitments are followed.

Skills

EU regulatory knowledge

Cross-functional collaboration

Regulatory operations

Project management

Education

University degree in Pharmacy/Pharmaceutical Sciences

Job description

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

We are looking for a Junior Regulatory Affairs Consultant tojoin regenold Portugal and grow within our international RegulatoryAffairs team.

This is an opportunity to build broad, hands-on experience inRegulatory Affairs. With guidance from experienced colleagues, you will supportEuropean regulatory projects, contribute to regulatory documentation andstrategies, and work closely with teams across regenold inGermany, the UK, Ireland and Portugal.

You will gradually take on increasing responsibility and gainexposure to international clients and regulatory activities throughout theproduct lifecycle. You may also contribute to projects involving medicaldevices, food supplements and cosmetics, while developing your expertise withinregenold Portugal's multidisciplinary team.

EU Regulatory knowledge

Cross-functional collaboration

Where you will make an impact

Regulatory Operations & Documentation

• Support national,decentralised, mutual recognition and centralised regulatory proceduresthroughout the product lifecycle
• Prepare, compile and reviewregulatory documentation for submissions in Portugal and across Europe
• Collaborate closely withexperts in Quality, Pharmacovigilance, CMC, Medical Devices and Market Accessto support integrated regulatory solutions

Stakeholder & Authority Engagement

• Support communications withnational competent authorities, the EMA and international clients
• Contribute to proposalpreparation, internal knowledge sharing and client meetings, as appropriate
• Support marketing authorisationapplications, variations, renewals, transfers and other post-authorisationactivities

Project Management Support

• Monitor regulatory developments and help assess their practical impact on clients and projects
• Maintain accurate projectrecords, trackers and regulatory databases, ensuring deadlines and commitmentsare followed

Your experience and skills

• University degree in Pharmacy,Pharmaceutical Sciences or another relevant life science
• Up to 2 years of professionalexperience in Regulatory Affairs; relevant internships or academic projects arealso valued
• Basic knowledge of Europeanregulatory procedures and the medicinal product lifecycle
• Motivation to learn, takeresponsibility and develop within a consulting environment
• Curious and keen to build a career in Regulatory Affairs in an international environment
• Detail - oriented, analytical thinking and aproactive, solution-oriented mindset
• Awareness of EU pharmaceuticallegislation and an interest in developing strong regulatory expertise
• Any experience with regulatorysubmissions, health authorities or international teams is considered anadvantage
• Knowledge of or exposure toeither Pharmacovigilance or pharmaceutical Quality Management Systems, throughprofessional experience, internships or academic training, is considered anadvantage.
• Strong organisationalskills and the ability to manage priorities and meet deadlines
• Very good written and spokenEnglish
• Additional European languagesare considered an advantage
• A permanent position withstructured onboarding, close support and increasing responsibility
• Varied international projectsfor pharmaceutical companies worldwide
• The opportunity to learn from ahighly 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 opportunitywithin a growing international consultancy, with clear scope to develop yourexpertise and responsibilities