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Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

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: Contract

Discipline: CMC

Location: Netherlands

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 Regulatory Consultant based in Amsterdam to support product launches and regulatory activities across Europe, Central Eastern Europe, and the Middle East. This role involves close collaboration with supply chain, quality assurance, commercial, and medical teams, as well as external regulatory partners. You will play a key role in ensuring compliance with country-specific regulatory requirements and supporting the lifecycle management of innovative products.

Responsibilities:

Collaborate with supply chain and quality assurance teams to identify regulatory requirements and risks, and assist with obtaining special import licenses and packaging waivers.
Partner with commercial and medical teams, as well as external regulatory consultants, to achieve business objectives.
Maintain relationships with distribution partners and regulatory consultancies to ensure smooth operations.
Prepare and deliver regulatory submissions, including Marketing Authorization Applications (MAAs), variations, and renewals, in collaboration with local partners.
Contribute to the development of new regulatory guidance and communicate its impact across the organization.
Provide input into the implementation of a Regulatory Information Management (RIM) system to track regulatory activities and support EU IDMP readiness.

Key Skills and Requirements:

A degree in Science or a related discipline; an advanced degree is desirable.
Knowledge of European regulatory requirements for innovative products in late-stage development and post-approval.
Experience working with National Competent Authorities in Europe.
Strong understanding of European Regulatory Affairs processes and associated requirements.
Ability to work effectively in a fast-paced, high-visibility environment with strong attention to detail.
Excellent analytical, problem-solving, and planning skills.
Strong communication skills in English, both verbal and written.
Results-driven, adaptable, and self-motivated with the ability to prioritize tasks effectively.
Comfortable working in a multicultural environment and enthusiastic about supporting new organizations 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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