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

JR Germany; Puchheim; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading medium-sized pharmaceutical company in Puchheim seeks a Senior Manager for Regulatory Affairs. The role involves managing regulatory submissions and communications with authorities, requiring a strong background in natural sciences and regulatory affairs. The ideal candidate will have excellent German and English skills, alongside leadership abilities. The company offers a flexible work environment, attractive benefits, and a commitment to employee well-being.

Leistungen

30 days of annual vacation

Flexible working hours including remote work options

Subsidized company pension plan

Financial support for job bikes

Coverage of the 'Deutschlandticket'

Subsidized lunch including free beverages

Seasonal fruit basket

Company events

EGYM Wellpass

Online employee discount portal via Corporate Benefits

Qualifikationen

• At least 5 years of experience in regulatory affairs for medicinal products.
• Excellent command of German at native level (C2) required.

Aufgaben

• Planning and submission of national change notifications and EU-variations.
• Communication with European competent authorities.
• Creation of eCTD sequences for submission.

Kenntnisse

Team Leadership

Analytical Thinking

Service Orientation

Proactive Thinking

Communication Skills

Ausbildung

University degree in natural sciences

Tools

eCTD

Regulatory Information Management Systems (RIMS)

Microsoft Office suite

Jobbeschreibung

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

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Client:

OmniVision GmbH

Location:

puchheim, Germany

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

5

Posted:

17.05.2025

Expiry Date:

01.07.2025

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Job Description:

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

In the course of our strong growth, we are looking for a committed and motivated person to join our headquarters in Puchheim near Munich as soon as possible:

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

• Planning and submission of national change notifications and EU-variations to competent authorities
• Compilation of variation packages regarding quality (CMC) and product information aspects
• Planning and submission of renewal applications
• Management of national and European variation and renewal procedures
• Communication with European competent authorities (EU and Switzerland)
• Answering letters of deficiency (List of Questions (LoQs))
• Procurement and assessment of documents from international suppliers (Contract Manufacturing Organizations (CMOs))
• Creation and revision of product information texts (SmPC, PIL, labelling) for the implementation of officially requested text amendments and/or for text adaptations to the current state of knowledge
• Coordination of all regulatory lifecycle management activities in the OmniVision subsidiaries (Austria, Italy, Spain and Switzerland)
• Creation of eCTD sequences for the submission of variation and renewal applications
• Maintaining and updating the company's internal marketing authorization database
• Collaboration in the company's internal change control process
• Monitoring, interpretation and implementation of new regulatory requirements
• University degree in natural sciences, preferably Pharmacy, Biology or Chemistry
• At least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EU
• Experience in creating eCTD sequences
• Open-minded personality
• Ability to lead a team
• Service-orientation
• Ability to grasp thinks quickly, analytical thinking in combination with an independent, structured and goal-oriented way of working
• Proactive thinking and acting, assertiveness, flexibility and strong communication skills
• For this position an excellent command of written and spoken German at the level of a native speaker (level C2) is required
• Fluent English with excellent verbal and written communication skills
• IT affinity: eCTD, databases, Regulatory Information Management Systems (RIMS), Microsoft Office suite
• Permanent, long-term employment in a successful, owner-operated medium-sized pharmaceutical company
• An attractive compensation package
• 30 days of annual vacation
• Flexible working hours including remote work options
• Modern IT infrastructure
• Modern and air-conditioned offices
• Ergonomic workstations
• Subsidized company pension plan
• Financial support for job bikes (company bicycle program)
• Coverage of the "Deutschlandticket" (nationwide public transportation ticket)
• Subsidized lunch including free beverages
• Seasonal fruit basket
• Company events
• EGYM Wellpass
• Online employee discount portal via Corporate Benefits