Proclinical is seeking a Regulatory Affairs Manager to provide strategic regulatory leadership and support product launches in Central Eastern Europe and the Middle East. This role involves close collaboration with supply chain, quality assurance, and commercial/medical teams to ensure compliance with country-specific regulatory requirements and manage potential risks.
Responsibilities:
- Provide strategic regulatory leadership to support product launches.
- Collaborate with supply chain and quality assurance to identify regulatory requirements and risks.
- Support obtaining special import licenses and packaging waivers.
- Lead regulatory review of commercial and medical materials.
- Manage relationships with distribution partners and regulatory consultancies.
- Conduct regulatory due diligence assessments with Business Development.
- Prepare and deliver regulatory submissions throughout the product lifecycle.
- Contribute to the preparation and communication of new regulatory guidance.
- Maintain a dashboard of country-specific regulatory activities.
- Provide input into the implementation of a Regulatory Information Management system (RIM).
Key Skills and Requirements:
- Degree in Science or another related discipline.
- Knowledge of European regulatory requirements for innovative products.
- Experience with product registration in the Middle East is a plus.
- Ability to work in a high-visibility, fast-paced environment.
- Strong analytical, problem-solving, and communication skills.
- Team player with the ability to work independently.
- Results-focused and able to meet deadlines.
- Adaptable, self-motivated, and able to prioritize effectively.
- Comfortable in a multi-cultural environment.
- Enthusiastic about supporting a new organization in different regions.
- Hands-on, entrepreneurial, and resourceful.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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.
