Management & Beratung Jobs

Proclinical is seeking a Associate Director Regulatory Affairs to develop and implement regional regulatory strategies for the development, registration, commercialization, and lifecycle management of assigned products/projects in the EMEA region (Europe, Middle-east, and Africa). This role also involves overseeing and managing affiliate level local Regulatory Affairs activities in Germany, Austria, and Switzerland.

Key Responsibilities:
- Develop and implement regional regulatory strategies for assigned products/projects.
- Collaborate closely with the Global Regulatory Lead, providing regional strategy and commercial input.
- Manage regulatory activities for the assigned products within the EMEA region.
- Oversee and manage 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.

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 Native German speaker.
- Minimum of 5 years 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.

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