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Senior Regulatory Affairs Specialist

2 months ago

King of Prussia, Pennsylvania, United States PAREXEL Full time
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team in Romania. This role can be based in our office in Bucharest or worked remotely from home.

As a Senior Regulatory Affairs Associate, you will have a few years of experience in Regulatory Affairs gained in the industry. You will bring expertise in Clinical Trial Applications (CTA) from various European locations and have a strong understanding of the regulatory landscape.

Key Responsibilities
  • Ensure client work is performed and delivered on time, meeting the quality expectations of the business and the client.
  • Take responsibility for ensuring compliance with regulatory requirements and guidelines.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies.
  • Provide guidance and support to junior team members.
Requirements
  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline.
  • Few years of experience in an industry-related environment.
  • Experience in clinical trial submissions to the competent Regulatory Authorities.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
  • Critical thinking and problem-solving skills.
  • Proficiency in English language.
What We Offer

We will provide you with training and knowledge of our organization's basic consulting models and methodologies, as well as basic knowledge of our services. You will have the opportunity to work on submissions for Parexel as well as dedicated for clients.

We are committed to supporting your growth and development in your career. You will have the chance to work on complex tasks with the support of more senior staff and may act in a client-facing role with clear guidance and support from line management.