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

Lisboa***,*** Portugal

About the role

We are looking for a Junior R****egulatory Affairs Consultant to join regenold Portugal and grow within our international Regulatory Affairs team.

This is an opportunity to build broad, hands-on experience in Regulatory Affairs. With guidance from experienced colleagues, you will support European regulatory projects, contribute to regulatory documentation and strategies, and work closely with teams across the regenold entities in Germany, the UK, Ireland and Portugal.

You will gradually take on increasing responsibility and gain exposure to international clients and regulatory activities throughout the product lifecycle. You may also contribute to projects involving medical devices, food supplements and cosmetics, while developing your expertise within regenold Portugal's multidisciplinary team.

Documentation & attention to detail

Regulatory knowledge

Organisational skills & deadline management

Cross-functional collaboration

Communication & stakeholder interaction

Where you will make an impact

Regulatory Operations & Documentation

• 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

Stakeholder & Authority Engagement

• Support communications with national competent authorities, the EMA and international clients
• Contribute to proposal preparation, internal knowledge sharing and client meetings, as appropriate
• Support marketing authorisation applications, variations, renewals, transfers and other post-authorisation activities

Project Management Support

• 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 Your experience and skills

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• University degree in Pharmacy, Pharmaceutical Sciences or another relevant life science
• Up to 2 years of professional experience in Regulatory Affairs; relevant internships or academic projects are also valued
• Basic knowledge of European regulatory procedures and the medicinal product lifecycle
• Motivation to learn, take responsibility 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 a proactive, solution-oriented mindset
• Awareness of EU pharmaceutical legislation and an interest in developing strong regulatory expertise
• Any experience with regulatory submissions, health authorities or international teams is considered an advantage
• Knowledge of or exposure to either Pharmacovigilance or pharmaceutical Quality Management Systems, through professional experience, internships or academic training, is considered an advantage.
• Strong organisational skills and the ability to manage priorities and meet deadlines
• Very good 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 structured onboarding, close support and increasing responsibility
• Varied international projects for pharmaceutical companies worldwide
• The opportunity to learn from 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, with clear scope to develop your expertise and responsibilities

International teams and projects

Flexible working hours