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registration specialist jobs near deutschland

Regulatory Affairs Specialist (Germany)

ProductLife Group -
Home Office

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Details zur Stelle

Festanstellung

Qualifikationen

Microsoft Office
Kommunikationsfähigkeit
Product Lifecycle Management

Vollständige Stellenbeschreibung

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.

Responsibilities:

1. 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.

2. Product Lifecycle Management

Manage post‑approval activities, including:
- Variations
- Renewals
- Product Information (SmPC, PIL, Labelling)
- Artwork review and updates
Ensure compliance with approved documentation throughout the lifecycle of assigned products.

3. 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
- Client‑specific procedures
Ensure readiness for internal and external audits.
Effectively manage Non‑Conformities (NCs) and CAPAs in a timely manner.

4. 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.

5. 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
- Veeva Vault or comparable EDMS
- LorenZ
- TrackWise
- PromoMats
Ensure accurate time and task tracking across assigned activities.

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
Product Information updates
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

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Erweiterte Suche

registration specialist Jobs in deutschland

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VPP Operations Specialist – Germany (m/w/d)

Ich möchte aktuelle Job-E-Mails für Stellen als registration specialist in deutschland erhalten

Weitere Job-Standorte erkunden

Responsibilities:

1. Submission & Registration Activities

2. Product Lifecycle Management

3. Regulatory Compliance & Quality

4. Health Authority Interaction & Communication

5. Systems, Tools & Data Management

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