jobid=A.0.0358
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.
Job opportunities
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:
+44 (0) 203 854 4609
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
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