Regulatory Affairs Specialist

ProductLife Group; Deutschland; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

PLG is a leading life sciences consultancy seeking a motivated Regulatory Affairs Specialist to join our team in Germany, with exposure to EU markets and a focus on full lifecycle compliance.

You will prepare MAAs and variations for Germany, support orphan drugs and line extensions, and interact with health authorities while coordinating with cross-functional teams in a multi-client consultancy setting.

Qualifikationen

• Degree in a life science discipline (Pharmacy, Biology, Chemistry or similar).
• 2–5 years of relevant Regulatory Affairs experience.
• Strong experience in German Regulatory Affairs.
• Proven experience across Product Lifecycle Management (New MAAs, Variations, Orphan Drugs, Line extensions, Artwork review).
• Experience interacting with Health Authorities; consultancy/multi-client setting is an advantage.

Aufgaben

• Prepare, submit Marketing Authorisation Applications (MAA) for Germany and EU countries.
• Support Orphan Drugs, line extensions, and launch readiness activities.
• Contribute to registration strategies and timelines with project teams and clients.
• Monitor regulatory requirements and ensure compliance throughout the product lifecycle.
• Act as a key contact with Health Authorities and respond to regulatory queries.
• Coordinate with cross-functional teams in a multi-client consultancy environment.

Kenntnisse

Regulatory affairs

German regulatory

Cross-functional collaboration

Documentation management

Ausbildung

Life sciences degree

Tools

Microsoft Office Suite

LorenZ

TrackWise

PromoMats

Jobbeschreibung

PLG is seeking a motivated and detail‑oriented Regulatory Affairs Specialist to join our Regulatory Affairs team.

In this role, you will be responsible for Regulatory Affairs activities primarily for Germany, with exposure to other EU markets, ensuring compliance throughout the full product lifecycle, from registration to post‑approval maintenance.

Submission & Registration Activities

• Prepare, compile, and submit Marketing Authorisation Applications (MAA), including new MAAs and variations, for Germany and assigned EU countries.
• Support Orphan Drugs, line extensions, and launch readiness activities.
• Contribute to registration strategies and timelines in collaboration with PLG project teams and clients.

Product Lifecycle Management

• Variations
• Renewals
• Product Information (SmPC, PIL, Labelling)
• Artwork review and updates
• Ensure compliance with approved documentation throughout the lifecycle of assigned products.

Regulatory Compliance & Quality

• Monitor and maintain up‑to‑date knowledge of national (Germany) and European regulatory requirements and legislation.
• Ensure full compliance with:
• Regulatory processes
• Assigned country regulations
• Ensure readiness for internal and external audits.
• Effectively manage Non‑Conformities (NCs) and CAPAs in a timely manner.

Health Authority Interaction & Communication

• Act as a key contact with Health Authorities, ensuring effective and professional communication.
• Support and respond to internal and client regulatory queries.
• Collaborate with cross‑functional teams in a multi‑client consultancy environment.

Systems, Tools & Data Management

• Use regulatory and document management systems to:
• Prepare correspondence and submissions
• Track regulatory activities and timelines
• Maintain databases and documentation
• Regularly work with tools such as:
• Microsoft Office Suite
• LorenZ
• TrackWise
• PromoMats
• Ensure accurate time and task tracking across assigned activities.

Required Experience

• Degree in a relevant life science discipline (Pharmacy, Biology, Chemistry, or similar)
• 2-5 years of relevant Regulatory Affairs experience
• Strong experience in German Regulatory Affairs
• Proven experience across Product Lifecycle Management, including:
• New MAAs
• Variations
• Orphan Drugs
• Line extensions
• Artwork review
• Experience interacting with Health Authorities
• Experience working in a consultancy and/or multi‑client setting is an advantage
• Good IT and digital tool proficiency
• Excellent organizational and communication skills
• Pro‑active mindset with the ability to work autonomously and in teams
• Willingness to take ownership and responsibility
• Ability to manage multiple priorities and workloads
• Experience in promotional / non‑promotional activities is a plus
• Experience in people coordination or mentoring is an advantage