Senior Regulatory Affairs Manager

TN Germany; Deutschland; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading global service provider is seeking a Senior Regulatory Affairs Manager in Germany. The role involves registering biocontrol products, preparing EU dossiers, and mentoring colleagues. Remote work is possible. Candidates should have a PhD and at least 5 years of relevant experience.

Qualifikationen

• Minimum 5 years of relevant experience with EU regulatory processes for biocontrol products.
• Fluent in English; additional languages are an asset.

Aufgaben

• Registering plant protection products according to EU Regulation (EC) 1107/2009.
• Preparing and coordinating EU SANCO dossiers for approval and renewal.

Kenntnisse

Project Management

Communication

Interpersonal Skills

Ausbildung

PhD in microbiology

PhD in molecular biology

PhD in chemistry

Jobbeschreibung

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Senior Regulatory Affairs Manager, Germany

Client: Knoell

Location: Germany

Job Category: Other

EU work permit required: Yes

Job Reference: a7b8ea1c2748

Job Views: 1

Posted: 11.05.2025

Expiry Date: 25.06.2025

Job Description:

Knoell is a leading global service provider offering regulatory registration, clinical development, and product development support. Our team of scientific and regulatory experts, along with our extensive network of partners, ensures compliance with regulatory requirements from the outset of each project, supporting our clients' global business. We value team spirit, mutual support, international cooperation, quality, and a growth mindset.

Position: Senior Regulatory Affairs Manager (f/m/d)

Location: Germany (Remote possible)

Responsibilities include:

• Registering plant protection products used in biocontrol and their active substances according to EU Regulation (EC) 1107/2009
• Preparing and coordinating EU SANCO dossiers for approval and renewal of biocontrol active substances
• Preparing and coordinating dRRs for authorization of biocontrol plant protection products in the EU
• Participating in pre-submission meetings with European authorities
• Providing post-submission support
• Developing registration strategies
• Sharing practical knowledge within a team
• Mentoring colleagues
• Conducting seminars on biocontrol registration for colleagues and clients
• Participating as a speaker at conferences
• Networking and acquiring new clients
• Maintaining contacts with authorities and key clients across Europe and globally

Candidate Profile:

• PhD in microbiology, molecular biology, microbial ecology, microbial biochemistry, biotechnology, genetics, biology, chemistry, or related fields
• Minimum 5 years of relevant experience with EU regulatory processes for biocontrol products
• Practical understanding of data requirements for registration
• Strong project management and interpersonal skills
• Excellent communication and presentation skills
• Fluent in English (spoken and written); additional languages are an asset

We look forward to receiving your application!