Manager Regulatory Affairs (m/f/d)

OmniVision GmbH; Puchheim; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

30 days annual leave

Flexible working hours

Mobile/remote work

Modern IT infrastructure

Air-conditioned offices

Company pension scheme

JobRad bike program

Commuting allowance

Subsidized lunch

Fruit basket

Company events

EGYM Wellpass

Employee discounts portal

Zusammenfassung

OmniVision GmbH in Puchheim near Munich is seeking a Manager Regulatory Affairs (m/f/d) to join our growing team. The role focuses on planning and submitting EU and national variations, renewal applications, and maintaining regulatory documents.

You will collaborate with authorities, ensure compliant product information texts, and monitor evolving regulations. Fluent German and English, plus IT affinity, are essential. We offer a permanent position with flexible hours and modern offices.

Qualifikationen

• University degree in natural sciences, preferably Pharmacy, Biology or Chemistry.
• Several years of regulatory affairs experience within the EU.
• Experience creating eCTD sequences.
• Strong teamwork and service orientation.
• Analytical, independent, and structured working style.
• Proactive, flexible, and communicative.
• Fluent German and English (oral & written).
• IT affinity: eCTD, databases, MS Office.

Aufgaben

• Planning and submission of national change notifications and EU-variations to competent authorities.
• 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 (CMOs).
• Creation and revision of product information texts (SmPC, PIL, labelling) for text amendments.
• Creation of eCTD sequences for submissions of variations and renewals.
• Maintaining and updating the company's internal marketing authorisation database.
• Collaboration in the internal change control process.
• Monitoring, interpretation and implementation of new regulatory requirements.

Kenntnisse

Regulatory affairs

EU submissions

eCTD sequences

Teamwork

Analytical thinking

Independent work

Communication skills

German & English

IT affinity

Ausbildung

University degree in natural sciences (Pharmacy/ Biology/ Chemistry)

Tools

eCTD software

Databases

Microsoft Office

Jobbeschreibung

Manager Regulatory Affairs (m/f/d)

OmniVision GmbHis a growing, mid-sized company in the field of ophthalmology, headquartered in Germany with additional locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision GmbH is among the leading independent ophthalmological companies not affiliated with a corporate group. Our product portfolio includes pharmaceuticals, medical devices, and dietary supplements.

Due to our strong growth, we are looking for a dedicated and motivatedManager Regulatory Affairs (m/f/d)to join our headquarters in Puchheim near Munich as soon as possible

Manager Regulatory Affairs (m/f/d)

OmniVision GmbHis a growing, mid-sized company in the field of ophthalmology, headquartered in Germany with additional locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision GmbH is among the leading independent ophthalmological companies not affiliated with a corporate group. Our product portfolio includes pharmaceuticals, medical devices, and dietary supplements.

Due to our strong growth, we are looking for a dedicated and motivatedManager Regulatory Affairs (m/f/d)to join our headquarters in Puchheim near Munich as soon as possible

Your Profile:

• University degree in natural sciences, preferably Pharmacy, Biology or Chemistry
• Several years of professional and practical experience in regulatory affairs (medicinal products) within the EU
• Experience in creating eCTD sequences
• Ability to work in a team, service-orientation
• Quick comprehension, analytical thinking in combination with an independent, structured and goal-oriented way of working
• Proactive thinking and acting, assertiveness, flexibility and strong communication skills
• Fluent in German and English with excellent oral and written communication skills
• IT affinity: eCTD, databases, Microsoft Office suite

Your contribution:

• Planning and submission of national change notifications and EU-variations to competent authorities
• 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 Organisations (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
• Creation of eCTD sequences for the submission of variation and renewal applications
• Maintaining and updating the company's internal marketing authorisation database
• Collaboration in the company's internal change control process
• Monitoring, interpretation and implementation of new regulatory requirements

What We Offer:

• A permanent, long-term oriented position in a successful, owner-managed, mid-sized pharmaceutical company
• An attractive compensation package
• Opportunities for further training and development
• 30 days of annual leave
• Flexible working hours, including mobile/remote work
• A modern IT infrastructure
• Modern, air-conditioned offices
• Ergonomic workstations
• Subsidized company pension scheme
• Financial support for a company bike (JobRad)
• Commuting allowance
• Subsidized lunch, including free beverages
• Seasonal fruit basket
• Company events
• EGYM Wellpass
• Online portal for employee discounts via Corporate Benefits