Translating regulatory complexity into successful market access across diverse global regions.
Proclinical is seeking a Regulatory Affairs Contractor to support regulatory activities across the EU and MENA regions. This role focuses on developing and implementing regulatory strategies for an innovative portfolio in rare diseases, supporting product lifecycle management, and ensuring compliance with country-specific requirements. The position requires a collaborative, hands-on professional who thrives in a fast-paced environment and can effectively communicate across diverse teams.
Responsibilities:
- Provide strategic regulatory guidance to Country Managers to facilitate successful product launches.
- Collaborate with supply chain and quality assurance teams to address country-specific regulatory requirements, risks, and special import licenses or packaging waivers.
- Lead regulatory reviews of commercial and medical materials in partnership with internal teams and external regulatory partners.
- Manage relationships with distribution partners and regulatory consultancies to achieve business objectives.
- Conduct regulatory due diligence assessments in collaboration with Business Development.
- Prepare and deliver regulatory submissions, including Marketing Authorization Applications (MAAs), variations, and renewals, in coordination with local partners.
- Monitor and communicate the impact of new regulatory guidelines across the organization.
- Maintain a dashboard of country-specific regulatory activities, including label management.
- Contribute to the implementation of a Regulatory Information Management (RIM) system to track regulatory activities and ensure readiness for EU IDMP compliance.
Key Skills and Requirements:
- 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, Africa, and Russia is advantageous.
- A blend of large company best practices and smaller company adaptability is ideal.
- Proven experience interfacing with National Competent Authorities in Europe.
- Ability to work effectively in a high-visibility, fast-paced environment with strong analytical and problem-solving skills.
- Team-oriented yet capable of working independently and taking ownership of responsibilities.
- Excellent verbal and written communication skills in English.
- Results-driven, adaptable, and self-motivated with strong planning and prioritization abilities.
- Comfortable working in a multicultural environment and enthusiastic about supporting new regional initiatives.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
Apply Now:
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