Regulatory Affairs Specialist (North America)

About the role

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. The role includes management of clinical trial applications to Competent Authorities, Ethics Committees, and Regulatory Agencies, as well as the research, review, and reporting on applicable global regulations and requirements.

Responsibilities

• Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise, and representation for the unit with other functional units, sponsors, researchers, and/or regulatory authorities.
• Ensure high-quality, timely service delivery processes are maintained in accordance with corporate, industry, and regulatory standards and guidelines.
• May coach peers and/or provide input for staff performance reviews.

Unit Management

• Coordinate the day-to-day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third-party vendors, and clinical sites.
• Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices.
• Communicate changes to project leaders in a timely manner.

Client Services

• Provide regulatory, ethics, and/or pharmacovigilance guidance and support to project stakeholders as the corporate subject specialist in regulatory affairs.
• Represent the unit at project meetings, assisting with project education/regulatory tool development, regulatory reviews, and audits.
• Engage with clients to ensure expectations are managed and met, and interact with regulatory, ethics, and government representatives.
• Respond to regulatory queries on behalf of the client when appropriate.

Regulatory Strategy Development

• Identify changes in clinical research regulatory requirements and industry best practices.
• Recommend, implement, and maintain corporate regulatory strategies, collaborating with other experts (safety, quality assurance) to meet or exceed compliance requirements of evolving regulatory initiatives.
• Participate in specialized conferences/meetings to increase knowledge as needed.

Project Support

• Regularly respond to registration requests and work with project teams to identify regulatory requirements.
• Assist in the preparation of regulatory submissions and support summaries.
• Ensure project/clinical site files and documents are developed, maintained, revised, archived, and/or destroyed in accordance with project and regulatory requirements.
• Ensure all project stakeholders are fully informed and trained on applicable regulatory requirements.

Qualifications

• Minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
• Strong knowledge of LATAM clinical trial regulations.
• Fluency in English and Spanish (written and verbal) required.

Working Conditions

Home-based.