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Regulatory Affairs Manager (m/w/d)
Frankfurt am Main
Aktualität: 01.08.2021


01.08.2021, Merz Therapeutics
Frankfurt am Main
Regulatory Affairs Manager (m/w/d)
Ensure and apply the regulatory knowledge for the assigned regions and countries to create high-quality documentation Carry out registration procedures and ensure compliance with internal requirements Implementation and support of 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 Coordination and implementation of change control processes and continuously tracking and maintaining the CMC submission and approval status Ensure worldwide labeling compliance by updating national product information texts and packaging materials according to company core data sheets, national requirements and internal processes Optimization of internal work processes and structures by cooperating with Merz departments and external partners worldwide Ensure all regulatory life cycle management activities and timely responses to authorities' inquiries Coordination of regulatory projects with the respective stakeholders and support regulatory strategies Preparation and participation in scientific consultations with regulatory authorities worldwide ´
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