Regulatory Affairs Team Lead

il y a 4 semaines

Courbevoie, Île-de-France ProductLife Group Temps plein

Regulatory Affairs Team Lead - European Union Expert

We are seeking a highly experienced Regulatory Affairs Team Lead to join our team at ProductLife Group. The ideal candidate will have a strong background in regulatory affairs, with a minimum of 5 years of experience in a European Union regulatory affairs department.

Key Responsibilities:

  • Manage and coordinate regulatory affairs projects, ensuring timely completion and compliance with EU regulations.
  • Lead a team of regulatory affairs specialists, providing guidance and support to ensure successful project outcomes.
  • Develop and maintain strong relationships with key stakeholders, including regulatory authorities and industry partners.
  • Stay up-to-date with the latest EU regulatory developments and ensure compliance with all relevant regulations.
  • Collaborate with cross-functional teams to ensure effective communication and project delivery.

Requirements:

  • Minimum 5 years of experience in a European Union regulatory affairs department.
  • Proven track record of managing and coordinating regulatory affairs projects.
  • Excellent leadership and communication skills, with the ability to motivate and guide a team.
  • Strong knowledge of EU regulations and guidelines, with the ability to interpret and apply them effectively.
  • Fluent English language skills, with the ability to communicate complex information effectively.

Preferred Qualifications:

  • Post-approval LCM experience for Module 1.
  • Excellent organizational and interpersonal skills.
  • Ability to work well within a team and share expertise.
  • Process-oriented with good attention to detail.
  • Effective oral and written communication skills.
  • Sense of responsibility and meeting deadlines.

Education:

Bachelor's or higher graduate degree in a science-related field, or equivalent experience.

Language Skills:

Very good English language and grammar skills are mandatory. Any other language on top of good English would be a plus.

Technical Skills:

  • Good computer skills and the ability to learn appropriate software.
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel.

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