Pharmaceutical Regulatory Specialist

il y a 4 semaines

Antony, Île-de-France Stallergenes Greer Temps plein

Job Opportunity: Regulatory Compliance Officer

Are you seeking a dynamic and rewarding position in the regulatory field? We have an exciting opportunity for you.

As a Regulatory Compliance Officer, your primary responsibility will be to ensure adherence to regulations and standards for pharmaceutical communications related to human health. Collaborating closely with the Director of Regulatory Expertise for Europe & International, your key duties will include:

  • Ensuring document adherence to European, French, and international regulations concerning pharmaceutical advertising
  • Revising legal disclaimers and evaluating their effects on current documentation
  • Contributing to preparatory discussions to advise project teams on feasibility
  • Aiding in the preparation of submissions for pharmaceutical usage approvals
  • Keeping abreast of regulatory developments

Qualifications:

The ideal candidate will possess a degree in Pharmacy, Engineering, or Regulatory Affairs, or have a background in Health and Drug Law, with at least 3 years of relevant experience.

A comprehensive understanding of European and French pharmaceutical regulations, along with ICH, EMA, and FDA guidelines, is essential.

Proficiency in managing promotional and non-promotional documents within the French and European framework is crucial, alongside strong computer skills (Microsoft Office).

In addition to being meticulous and possessing strong analytical and synthesis abilities, you should be organized, self-sufficient & inquisitive.

Excellent interpersonal skills and a collaborative mindset are highly valued.

Proficiency in English: reading, writing, and speaking is required.

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