Associate Director Regulatory Affairs - EMEA job in Frankfurt am Main (60488), Germany

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Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: Germany

This vacancy has now expired. Please see similar roles below...

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.

Apply Now:
If you are having difficulty in applying or if you have any questions, please contact our consultant at J.pawl@proclinical.com

About Proclinical:
Proclinical is a leading recruiter in the life sciences sector, dedicated to pairing exceptional talent with top positions globally. Want to stay updated? Follow us and check out our website for live roles and updates www.proclinical.com

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