Regulatory Affairs Manager (m/w/d)

60306, Frankfurt am Main
20.01.2021

Daten dieser Anzeige

Job-ID: 019600355
Regulatory Affairs Manager (m/w/d)

Merz Therapeutics

Germany

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You ensure and apply the regulatory knowledge for the assigned regions and countries to create high-quality documentation. You carry out registration procedures and ensure compliance with internal requirements. You implement and support regulatory activities for preparation and submission of applications for new registrations, approval dossiers and GMP verification of the documentation in accordance with national regulatory requirements. You coordinate and implement change control processes and continuously track and maintain the CMC submission and approval status. You ensure worldwide labeling compliance by updating national product information texts and packaging materials according to company core data sheets, national requirements and internal processes. You optimize internal work processes and structures by cooperating with Merz departments and external partners worldwide. You ensure all regulatory life cycle management activities and timely responses to authorities' inquiries. You coordinate regulatory projects with the respective stakeholders and support regulatory strategies. You prepare and participate in scientific consultations with regulatory authorities worldwide.

Our leading position in the global market in the areas of Therapeutics, Aesthetics and Consumer Care is the result of our innovative spirit and the commitment of our staff. Our highly attractive portfolio, a strong strategic focus, and dynamic characterize us as a company that is heading towards long-term growth and success. Do you share our enthusiasm for customer-oriented work and are willing to take up the task of continuing to write our success story? Then join the Merz Therapeutics Business of Merz Pharmaceuticals GmbH as  Global Regulatory Affairs  Merz Therapeutics THESE TASKS ARE WAITING FOR YOU:  You ensure and apply the regulatory knowledge for the assigned regions and countries to create high-quality documentation. You carry out registration procedures and ensure compliance with internal requirements. You implement and support regulatory activities for preparation and submission of applications for new registrations, approval dossiers and GMP verification of the documentation in accordance with national regulatory requirements. You coordinate and implement change control processes and continuously track and maintain the CMC submission and approval status. You ensure worldwide labeling compliance by updating national product information texts and packaging materials according to company core data sheets, national requirements and internal processes. You optimize internal work processes and structures by cooperating with Merz departments and external partners worldwide. You ensure all regulatory life cycle management activities and timely responses to authorities' inquiries. You coordinate regulatory projects with the respective stakeholders and support regulatory strategies. You prepare and participate in scientific consultations with regulatory authorities worldwide. THIS IS WHAT WE EXPECT FROM YOU:  Pharmacist or PhD in natural sciences or comparable academic background At least 4 years of regulatory experience in medicinal products in the pharmaceutical industry in a similar position Experienced in registration or marketing authorization of medicinal products and itslife cycle management in non-EU countries Business fluent in German and English language Creative mindset and innovative thinking and problem-solving skills Excellent communication skills, flexibility and perseverance Professional user skills of standard software business applications WHAT YOU CAN EXPECT FROM US:    Creative and modern working environment in a family owned business Meaningful tasks and exciting projects from day one Collaboration in multi-functional international teams High working time flexibility Attractive conditions and social benefits Personal and professional development opportunities   >> Hier bewerben   Merz is a growing international company with its headquarters in the heart of Frankfurt, offering a competitive compensation and benefits package, flexible working environment and numerous professional development opportunities. We look forward to receiving your online application - please be sure to include your salary expectations and your earliest start date.

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Technische Berufe/ Fertigung/ Produktion

Ingenieurwesen

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

60306

Frankfurt am Main