Description
We are seeking a Regulatory Team Leader to work independently under limited supervision on complex projects. You will act as a Regulatory Team Leader, write regulatory and technical documents, establish relationships with customers, and undertake detailed review and management of budgets.
Responsibilities:
- Act as a Regulatory Team Leader on complex projects
- Write regulatory and technical documents with minimal review by senior staff
- Establish relationships with many customers and discuss regulatory issues
- Undertake detailed review and management of budgets related to projects
- Give guidance to junior colleagues and assist in their training and development
- Present to clients at bid defense meetings
- Write new regulatory standard operating procedures and propose revisions
- Perform other tasks or assignments as delegated by Regulatory management
Requirements:
- Bachelor's or Master's Degree in Life Science or related discipline
- At least 8 years of relevant experience
- Good understanding of the Research and Development process, laws, and related guidelines
- Specific regulatory or technical expertise
- Expert in planning and delivering work on time with quality parameters in mind
- Knowledge of regulatory procedures in the appropriate region
- Good working knowledge of regional regulatory intelligence
- Ability to work closely with client regional heads and establish effective working relationships
- Strong software and computer skills, including Microsoft Office and publishing applications
- Ability to work on several projects with direction from senior staff
- Ability to follow standard operating procedures consistently and provide independent thought
- Advanced knowledge within a specific discipline typically gained through extensive work experience and/or education