Regulatory Affairs Expert

2 semanas atrás

São Paulo, Brasil beBeeRegulatory Tempo inteiro

**Senior Regulatory Specialist Job Description**

We are seeking a highly skilled and experienced Senior Regulatory Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

**Key Responsibilities:**

  • Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate the collection and organization of data and information required by regulatory authorities.
  • Liaise with internal and external vendors to generate regulatory authority submissions.
  • Ensure start-up and maintenance activities are on track and compliant with applicable laws and guidelines.

**Critical Tasks:**

  • Collect and track necessary documents, perform quality review, formatting, and compilation of final documents for effective site activation and maintenance.
  • Review and customize country and site-specific patient informed consent forms for compliance with local requirements.
  • Identify and escalate risks to meeting deliverables.

**Requirements:**

  • University degree (life science preferred), or certification in a related allied health profession AND 2 years' work experience in clinical research.
  • Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.

**Skills and Qualifications:**

  • Minimum of 3 years of experience in clinical development or start-up/regulatory process.

**About You:**

  • Passionate about regulatory affairs and committed to delivering high-quality results.
  • Excellent communication and project management skills.
  • Able to work effectively in a team environment.

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