EMEA Senior Regulatory Affairs Manager

vor 4 Wochen

Munich, Bayern, Deutschland Proclinical Vollzeit

Proclinical is on the lookout for a Senior Regulatory Affairs Manager. In this role, you will be responsible for developing and implementing regional regulatory strategies for the development, registration, commercialisation, and lifecycle management of assigned products/projects in the EMEA region. You will also manage affiliate level local Regulatory Affairs activities in Germany, Austria, and Switzerland.

Responsibilities:

Develop and implement regional regulatory strategies for assigned products/projects.Collaborate with the Global Regulatory Lead, providing regional strategy and commercial input.Manage regulatory activities for the assigned products within the EMEA region.Oversee affiliate level local Regulatory Affairs activities in Germany, Austria, and Switzerland.Build and maintain relationships with key regulatory stakeholders in EMEA.Perform regulatory intelligence activities, including competitor product label investigations & strategy definition.Monitor and anticipate trends in the region impacting the regulatory and market landscape.Prepare and coordinate the compilation of relevant Product Information and CCDS for assigned products.Review promotional materials and secondary packaging materials to ensure compliance with regulatory approved texts.Develop, prepare, and maintain SOP's and working procedures for regulatory affairs tasks.Provide regulatory support for pricing and reimbursement issues as needed.Key Skills and Requirements:Bachelor's degree or higher in a life science discipline such as biology, chemistry, pharmacy, or toxicology.Fluency in written and spoken English and German.Experience in medicinal product Regulatory Affairs in Europe.Experience working with regulatory agencies in Germany, Austria, and/or Switzerland.Deep understanding of the medicinal legislation and guidelines in Europe/EMEA.Expert knowledge of the regulatory submission process in the region.Demonstrated understanding of business and regulatory cultures across EMEA.Expertise in preparing Marketing Authorisation Applications and other regulatory submissions in Europe.Good written and verbal communication skills.Strong teamwork and collaboration skills. If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer. #Regulatory

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