Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
Proclinical is seeking a Senior Manager of Regulatory to support regulatory activities across Central Eastern Europe, Israel, North Africa, and the Middle East. In this role, you will contribute to the development and implementation of regulatory strategies for an innovative product portfolio. This position requires a hands-on approach, effective collaboration across teams, and strong communication skills in a dynamic environment. This position is based out of Holland with 2 days required in Amsterdam per week.
Responsibilities:
- Manage country-specific regulatory activities to ensure successful product launches in the assigned regions.
- Collaborate with internal and external partners to identify regulatory requirements, assess risks, and support processes such as obtaining special import licenses and packaging waivers.
- Build and maintain relationships with distribution partners and regulatory consultancies to meet business objectives.
- Define submission strategies, prepare applications (including authoring), and oversee submissions throughout the product lifecycle, including marketing authorization applications, variations, and renewals.
- Maintain a dashboard to track country-specific regulatory activities, including label management.
- Provide input into the implementation of a Regulatory Information Management (RIM) system to effectively monitor regulatory activities at the country level.
Key Skills and Requirements:
- A degree in Science or a related discipline; an advanced degree is desirable.
- Strong knowledge of European regulatory requirements for innovative products in late-stage development and post-approval.
- Experience with product registration in the Middle East is a plus.
- A blend of large company best practices and smaller company adaptability is ideal.
- Proven expertise in Regulatory Affairs, including interactions with National Competent Authorities.
- Ability to thrive in a fast-paced, high-visibility environment with strong attention to detail and problem-solving skills.
- A team player who can also work independently, taking ownership and responsibility for tasks.
- Excellent verbal and written communication skills in English.
- Results-driven, adaptable, and capable of prioritizing effectively under pressure.
- Enthusiastic about working in a multicultural environment and supporting new organizational efforts in diverse regions.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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