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 general/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.
Responsabilities
- 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 strategy and technical expertise.
- Prepares/reviews core packages and country packages for submission to RA (initial applications,
amendment packages, and notifications) in assigned countries to ensure compliance.
- Peer review of documents and packages prepared by colleagues within regulatory team.
- Develops/reviews Country ICFs.
- Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites.
- Develops/reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements.
- Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs
- Act as a mentor to new or junior colleagues within regulatory team. Responsibilities could include helping in assigning work; coaching/training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory/ethics