EMEA Senior Regulatory Affairs Manager

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 J.pawl@proclinical.com

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