Job Description

• Maintains current knowledge and actively monitors and researches the

Regulatory PV and safety reporting landscape commensuration with their Regulatory Intelligence country-specific role and

assignment of specific topics.

• Evaluates regulatory changes, proactively assess the impact, and takes all the necessary actions in a timely manner resulting due to the update. (such as decimating the updates to teams, updating specific systems concerned etc.)

• Helps fellow team members and other colleagues with enquiries related to their country specific regulatory intelligence.

• Liaison with internal departments regarding regulatory changes and impact on business and in specific PV department.

• Communicates with regulatory authorities, ethics committees and third parties as required for evaluating regulatory changes.

• Receives, prepares, and submits safety reports to applicable parties, ensuring compliances at all stages.

• Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress. Exercises independent judgment to troubleshoot, resolves project issues and identifies areas for improvement.

• Leads and monitors large and complex projects effectively to ensure that all aspects of the project are completed successfully and on time.

• Attends and presents at various meetings as required.

• Facilitates and advises on company, client and regulatory audits where required.

• Provides training and support to lower-level team members, mentors new starters, provides input on individual performance and shares ideas and suggestions with team members.

• Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.