Job Description
The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.
This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally. This role will also support the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees and company initiatives.
Responsibilities
- Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Lead global/multinational submissions of complex large clinical trials.
- Addresses Sponsor queries related to regulatory and submission requirements.
- Provides regulatory support and advice to project teams; provides project-specific local submission...