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

OmniVision GmbH

is 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 motivated

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

to join our headquarters in Puchheim near Munich as soon as possible.

Your Contribution:

Planning and submission of national change notifications and EU-variations to competent authorities

Planning and submission of renewal applications

Compilation of variation packages regarding quality (CMC) and product information aspects

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

Your Profile:

University degree in natural sciences, preferably in 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 combined with an independent, structured and goal-oriented work style

Proactive thinking and acting, assertiveness, flexibility and strong communication skills

Fluent in German and English with excellent verbal and written communication skills

IT affinity: eCTD, databases, Microsoft Office suite

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

Does this sound interesting to you?

We look forward to receiving your application, including a cover letter stating your salary expectations and earliest possible start date, your CV, and relevant references/certificates, addressed to Francisco Lopez, Senior HR Manager.

We ask recruitment agencies to refrain from contacting OmniVision.

OmniVision GmbH

Lindberghstrasse 9 | 82178 Puchheim bei München

www.omnivision.de