Senior Regulatory Affairs Associate

7 days ago

King of Prussia PA United States Parexel International Corporation Full time

We are recruiting for a French Speaking Senior Regulatory Affairs Associate in Europe. We can consider candidates based in Romania, Poland, Lithuania or UK, it is essential that you have fluent French and English language skills and strong CTA experience.

This Senior Regulatory Affairs Associate- CTA will support CTA submissionsfor the following countriesBelgium, France, Luxembourg and Monaco for trial submitted according to the EU-directive but also submission of Managed Access Program (MAP) and Non-international studies (NIS). You will be responsible for managing and submitting the dossier to those competent authorities but also to review the clinical trial labels in for those labels and make the French translation.

Key Responsibilities:

  • Local submission of CTA according to the EU directive until the end of the transition period in Belgium, France, Luxembourg and Monaco, then submission according to EU-CTR
  • Local submission of MAP and NIS

Education:
- Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

Language skills :
- Must be fluent in French and Englishcommunication skills in both written and verbal format (German would also be a bonus to have).

Skills:
- High-level consulting skills
- Critical thinking and problem-solving skills
- Project leadership and management knowledge
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Proficiency in local language and extensive working knowledge of the English language
- Networking
- Business analysis
- Self-confidence and control

Knowledge and Experience:
- Strong experience working in a CRO industry-related environment; experience with a regulatory agency is a plus
- Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant with CTA submission knowledge is essential, knowledge in MAP and NIS would be a plus
- Knowledge and understanding of reviewing the clinical trial labels in those countries and French translation is required.
- Client-focused approach to work
- Regulatory Project Management/Lead experience.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey

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