Senior Regulatory Affairs Associate

Are you ready to embrace the flexibility of remote work and drive innovation, collaboration, and growth-no matter where you are? Proclinical is seeking a Senior Regulatory Affairs Associate to support product launches across Europe, Central Eastern Europe, and the Middle East. You will collaborate with supply chain and quality assurance teams to navigate country-specific regulatory requirements and risks. Your role involves working closely with commercial, medical teams, and external partners to ensure business objectives are met. This position requires you to contribute to application preparations and submissions throughout the product lifecycle, including marketing authorizations, variations, and renewals. Additionally, you will assist in implementing a Regulatory Information Management system to track regulatory activities effectively.

Responsibilities:

• Support product launches in specified regions.
• Collaborate with supply chain and quality assurance to identify regulatory requirements and risks.
• Partner with commercial and medical teams, and external regulatory partners.
• Maintain relationships with distribution partners and consultancies.
• Prepare and deliver submissions for product lifecycle management.
• Contribute to new regulatory guidance preparation and communicate impacts.
• Assist in implementing a Regulatory Information Management system.

Key Skills and Requirements:

• Degree in Science or related field; advanced degree preferred.
• Knowledge of European regulatory requirements for innovative products.
• Experience with large and small company practices.
• Familiarity with European Regulatory Affairs and National Competent Authorities.
• Ability to work in a fast-paced, high-visibility environment.
• Strong analytical, problem-solving, and communication skills.
• Team player with initiative and ownership.
• Results-focused, adaptable, and self-motivated.
• Comfortable in a multicultural environment.