Manager:in Regulatory Affairs

OmniVision GmbH; München; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Permanent position

Attractive remuneration package

Annual leave 30 days

Flexible working hours

Mobile working

Modern IT infrastructure

Employee parking spaces

Pension scheme subsidy

Job bike support

Germany Ticket

Catering subsidies

Company events

Job summary

OmniVision GmbH, a growing ophthalmology company with HQ in Germany, seeks a Manager Regulatory Affairs to join our Munich-area headquarters in Puchheim. You will lead planning and submission of EU variations and national changes, manage renewal procedures, and liaise with European authorities.

Requirements include a degree in natural sciences (pharmacy/biology/chemistry), several years in EU regulatory affairs, experience with eCTD sequences, and strong German and English communication.

Qualifications

• Bachelor's or Master’s degree in natural sciences (preferred: Pharmacy, Biology or Chemistry).
• Several years of practical regulatory affairs experience for medicinal products in the EU.
• Experience creating eCTD sequences.
• Strong team player with service orientation.
• Analytical, independent and goal-oriented work style.
• Proactive, assertive, flexible, and with strong communication skills.
• Fluent in German and English, with excellent written and spoken skills.

Responsibilities

• Plan and submit national change notifications and EU variations to authorities.
• Prepare variation packages for quality (CMC) and product information aspects.
• Plan and submit renewal applications.
• Manage national and EU variation and renewal procedures.
• Communicate with European authorities (EU and Switzerland).
• Respond to letters of deficiency (LoQs).
• Coordinate with CMOs for documents.
• Create and revise SmPC, PIL, and labeling texts.
• Create eCTD sequences for submissions.
• Maintain internal marketing authorisation database.
• Collaborate in change control processes.
• Monitor and implement new regulatory requirements.

Skills

Teamwork

Analytical thinking

Independent working

Communication skills

German and English

Proactiveness

Education

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

Tools

eCTD sequences

Job description

OmniVision GmbH 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:

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

Your contribution:

• 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 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 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

We offer you:

• A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry
• An attractive remuneration package
• Further training opportunities
• Annual leave of 30 days
• Flexible working hours including mobile working
• A modern IT infrastructure
• Modern offices with employee parking spaces
• Subsidy for the company pension scheme
• Financial support for a job bike
• Payment of the Germany ticket
• Subsidized company catering including free drinks
• Company events

Does this sound interesting to you?