Regulatory Affairs Consultant

Job Title: Regulatory Affairs Consultant (Freelancer)

Location: Netherlands, remote-based

Duration: 3 months

Company Overview:

Apsida Life Science is currently partnering with a leading global clinical research organization (CRO) that provides comprehensive drug development and regulatory consulting services to the biopharmaceutical industry. With a strong focus on clinical trials, regulatory affairs, and real-world evidence, this company supports pharmaceutical and biotech companies in bringing innovative therapies to market efficiently and in compliance with international standards.

Responsibilities:

To provide general advice for French local procedures and support for the following:

• Communicate with authorities on the Marketing Authorisation Holder ("MAH") behalf,
• Regulatory check of promotional materials and necessary communication with regulatory bodies,
• Perform regulatory intelligence, not related to regulatory procedures,
• Regulatory support for pricing,
• Regulatory advice on maintaining approved MA,
• A resource will be allocated to this task,
• Perform regulatory output. Our Client will provide medical or access support, if required.
• Communicate with authorities based on the PoA provided by our Client
• Provide advice or support regarding labelling and artwork development and requirements (not limited to EN pack and/or multilingual pack/'worst case' pack development, provision of spec-imens, local blue box requirements)
• Provision of translations and linguistic review support for production information & related annexes in all required languages, including submission-ready document package

Qualifications:

• Bachelor's degree in a life science, pharmacy, chemistry, biomedical engineering, or a related field.
• Preferred: Master's degree or PhD in life sciences or a Regulatory Affairs-focused program (e.g., MSc in Regulatory Science, MBA with healthcare focus).

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

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Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process