Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

• Provides operational support to the Clinical Research organization to ensure the wellbeing of clinical research subjects and the best possible project outcomes.
• Prepares and reviews regulatory submissions on behalf of clinical research studies and secures marketing authorizations.
• Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables; communicates regulatory issues and opportunities to customers; and provides strategic regulatory guidance to project teams.

• JOB OVERVIEW

  Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorization activities for either internal and/or external clients.  Independently provides regulatory support for more complex projects.

  Responsibilities

• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
• Competently writes regulatory and/or technical documents with minimal review by senior staff.
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned.  Adopts a proactive and flexible approach to resolve any issues.
• Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognized and challenges when appropriate, may seek guidance from senior staff as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
• May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate.
• May be involved in a Regulatory and/or internal Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.

• MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  Experience

  Typically requires 3 - 5 years of prior relevant experience.

  Knowledge

  Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.