Regulatory Affairs Specialist

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