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

OmniVision GmbH; Ravenna; In loco; EUR 60.000 - 85.000; Tempo pieno

Descrizione del lavoro

OmniVision GmbH, a leading ophthalmology company, is seeking a Senior Manager in Regulatory Affairs for its offices in Italy. The role involves oversight of regulatory processes for medicinal products, with a focus on compliance and effective communication with authorities. The ideal candidate will have substantial experience in the EU regulatory environment and exhibit strong leadership qualities. The company offers an attractive compensation package and flexible work options.

Servizi

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

Competenze

• Minimum 5 years experience in regulatory affairs (medicinal products) within the EU.
• Fluency in German and English required.
• Experience in creating eCTD sequences is essential.

Mansioni

• Planning and submission of national change notifications and EU-variations.
• Management of national and European variation and renewal procedures.
• Communication with European competent authorities.

Conoscenze

Analytical Thinking

Team Leadership

Service Orientation

Proactive Thinking

Strong Communication

Formazione

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

Strumenti

eCTD

Regulatory Information Management Systems (RIMS)

Microsoft Office suite

Descrizione del lavoro

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

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 :

Your Profile :

• 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 things 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
• Fluent in German and English with excellent oral and written communication skills
• IT affinity : eCTD, databases, Regulatory Information Management Systems (RIMS), Microsoft Office suite

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 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

We offer you :

• 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

Does this sound interesting to you?

We look forward to receiving your application (cover letter stating your salary expectations and earliest possible starting date, CV and references) to the attention of Francisco Lopez, HR Manager.

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