Description
We are seeking an experienced Regulatory Team Leader to work independently on complex projects, providing technical writing and project management expertise. You will establish relationships with customers, manage budgets, and provide guidance to junior colleagues.
Key Responsibilities:
- Act as Regulatory Team Leader on complex projects, including technical writing and project management
- Write regulatory and technical documents with minimal review by senior staff
- Establish relationships with customers and resolve issues proactively
- Manage budgets and ensure revenue recognition
- Provide guidance to junior colleagues and assist in their training and development
- Present to clients at bid defense meetings
- Develop and implement regulatory standard operating procedures
- Manage meetings with Regulatory Agencies
- Support global regulatory or technical initiatives
Requirements:
- Bachelor's degree in Life Sciences or related discipline
- Master's degree in Life Sciences or related discipline preferred
- At least 6 years of relevant experience in regulatory procedures in Brazil
- Knowledge of Brazilian regulatory intelligence and CMC activities
- Ability to work closely with client regional heads and establish effective working relationships
- Strong software and computer skills, including Microsoft Office and regulatory tools
- Experience in regulatory strategy and determination of documentation requirements
- Project leadership experience
Preferred Experience:
- Extensive experience in regulatory lifecycle management in Brazil
- Strong experience in assessment, preparation, review, submission, and management of post-registration applications
- Demonstrated experience in management and oversight of regulatory submissions involving local legal documentation and Health Authority requirements