Senior Manager Regulatory Affairs (m/w/d) - Medicinal Products

JR Germany; München; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An expanding medium-sized pharmaceutical company is seeking a Senior Manager for Regulatory Affairs in Munich. This role involves planning and submitting regulatory submissions, managing variations, and collaborating with European authorities. The ideal candidate will possess a strong background in EU regulatory affairs, excellent communication skills, and a proactive attitude. Join a dynamic team in a supportive environment that values your contributions and offers flexible working options, a competitive salary, and a comprehensive benefits package.

Leistungen

30 days annual vacation

Flexible working hours

Modern IT infrastructure

Ergonomic workstations

Subsidized pension plan

Support for job bikes

Public transportation support

Qualifikationen

• 5+ years of EU regulatory affairs experience for medicinal products.
• Experience in creating eCTD sequences and managing regulatory submissions.

Aufgaben

• Plan and submit national change notifications and EU variations.
• Communicate with European authorities and manage renewal procedures.

Kenntnisse

EU regulatory affairs experience

eCTD sequence creation

communication skills

analytical skills

team leadership

Ausbildung

University degree in natural sciences

Tools

eCTD

databases

RIMS

Microsoft Office

Jobbeschreibung

Social network you want to login/join with:

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Client:

OmniVision GmbH

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

05.05.2025

Expiry Date:

19.06.2025

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Job Description:

OmniVision GmbH is an expanding medium-sized ophthalmology company headquartered in Germany, with locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision is one of the leading non-corporate ophthalmology companies, offering pharmaceuticals, medical devices, and nutritional supplements.

We are seeking a committed and motivated individual to join our headquarters in Puchheim near Munich as soon as possible:

Senior Manager Regulatory Affairs (m/f/d) - Medicinal Products

• Planning and submitting national change notifications and EU variations to authorities
• Compiling variation packages related to quality (CMC) and product information
• Planning and submitting renewal applications
• Managing national and European variation and renewal procedures
• Communicating with European authorities (EU and Switzerland)
• Responding to letters of deficiency (LoQs)
• Procurement and assessment of documents from international suppliers (CMOs)
• Creating and revising product information texts (SmPC, PIL, labels)
• Coordinating regulatory lifecycle activities across subsidiaries in Austria, Italy, Spain, and Switzerland
• Creating eCTD sequences for submissions
• Maintaining the internal marketing authorization database
• Collaborating in internal change control processes
• Monitoring and implementing new regulatory requirements

Requirements:

• University degree in natural sciences (Pharmacy, Biology, Chemistry preferred)
• Minimum 5 years of EU regulatory affairs experience for medicinal products
• Experience in creating eCTD sequences
• Open-minded, team leadership skills, service-oriented
• Quick learner, analytical, independent, structured, goal-oriented
• Proactive, assertive, flexible, strong communication skills
• Fluent in German and English, excellent communication skills
• IT skills: eCTD, databases, RIMS, Microsoft Office

Benefits include:

• Permanent employment in a successful, owner-operated medium-sized pharmaceutical company
• Attractive compensation package
• 30 days annual vacation
• Flexible working hours with remote options
• Modern IT infrastructure and air-conditioned offices
• Ergonomic workstations
• Subsidized pension plan
• Support for job bikes and public transportation (