Regulatory Affairs Consultant

Job Title: Regulatory Affairs Consultant

Location: France

Work Arrangement: Fully Remote

Contract Duration: 1 January 2027- 31 December 2027

Hours: 5–10 hours/ month (Ad-hoc/ on demand)

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Company overview:

Apsida Life Science is partnering with a leading global Contract Research Organisation (CRO) that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development and delivery of innovative therapies. With decades of industry experience and a global presence, the organisation provides expertise in clinical development, regulatory consulting, market access, and real-world evidence to help bring new treatments to patients worldwide.

Key Responsibilities:

• Provide regulatory support for biosimilar products in the French market.
• Review promotional and medical materials from a regulatory perspective.
• Support national aRMM (additional Risk Minimisation Measures) activities.
• Provide support with French regulatory compendia activities.
• Manage and support regulatory interactions with ANSM (Agence nationale de sécurité du médicament et des produits de santé).
• Provide ad hoc regulatory advice and guidance as required.
• Ensure activities are aligned with applicable French regulatory requirements and expectations.

Requirements:

• Strong experience in Regulatory Affairs within France.
• Proven experience working with ANSM and French regulatory requirements.
• Experience with biosimilar products is highly desirable.
• Experience reviewing promotional materials from a regulatory perspective.
• Knowledge of aRMM requirements and activities in France.
• Familiarity with French regulatory compendia.
• Strong understanding of the French pharmaceutical regulatory environment.
• Ability to work independently and provide flexible, on-demand support.
• Excellent communication and stakeholder-management skills.

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

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. xzewmjt 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.