Junior Regulatory Affairs Consultant

Regenold; Almada; Hybrid; EUR 23,000 - 32,000; Full time

Job summary

Regenold seeks a Junior Regulatory Affairs Consultant to support European regulatory projects and contribute to documentation and strategies. You will work with cross-functional teams across Regenold entities in Germany, the UK, Ireland and Portugal, gradually taking on more responsibility in a dynamic international setting.

The role offers a structured onboarding, mentoring, and increasing responsibility within a multidisciplinary team handling Regulatory Affairs, Quality, Pharmacovigilance,

Qualifications

• University degree in Pharmacy, Pharmaceutical Sciences or life science.
• Up to 2 years of professional experience in Regulatory Affairs.
• Basic knowledge of European regulatory procedures and the medicinal product lifecycle.
• Awareness of EU pharmaceutical legislation.

Responsibilities

• Prepare, compile and review regulatory documentation for submissions in Portugal and across Europe.
• Collaborate with Quality, Pharmacovigilance, CMC, Medical Devices and Market Access teams.
• Maintain accurate project records, trackers and regulatory databases, ensuring deadlines are met.
• Support communications with national authorities, EMA and international clients.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

English proficiency

Attention to detail

Communication

Education

Pharmacy degree

Job description

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

We are looking for a

Junior R

egulatory Affairs Consultant

tojoin

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 oracademic 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