Manager, Regulatory Affairs
Johnson & Johnson
Job Level
Mid-LevelSenior
About the role
- Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.
- Manage clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies.
- Research, review and report on applicable global regulations and requirements.
- Develop stakeholder tools and process/document regulatory risk assessments.
- Provide regulatory, ethics and pharmacovigilance guidance and support to project stakeholders and represent the unit with functional units, sponsors, researchers and regulatory authorities.
- Coordinate compilation of regulatory filings, submissions and revisions for projects, third party vendors and clinical sites.
- Conduct or assist with regulatory and safety reviews; create regulatory-related tools and educational/training materials.
- Represent the unit at project meetings, regulatory reviews, audits and respond to regulatory queries on behalf of the client when appropriate.
- Identify changes in clinical research regulatory requirements and recommend and implement corporate regulatory strategies.
- Respond to registration requests and assist in preparation of regulatory submissions and support summaries.
- Ensure project and clinical site files/documents are maintained, archived and destroyed per project and regulatory requirements and that stakeholders are informed and trained on applicable regulatory requirements.
Requirements
- Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
- The successful candidate will possess strong knowledge of EMA regulations.
