Not specified; competitive within each country; ra...
Fully remote
Expert knowledge in small and large molecules
Experience with biologics, cgt, adc, and vaccines
Preparation of regulatory cmc submission documents
The role involves providing expert knowledge on the technical development, testing, and manufacturing of various drug modalities including biologics and gene therapies
Job Summary
The role involves providing expert knowledge on the technical development, testing, and manufacturing of various drug modalities including biologics and gene therapies.
Candidates will manage the preparation of regulatory CMC submission documents for major applications like INDs, NDAs, and BLAs while facilitating approvals through agency negotiations.
ICON offers a competitive salary, diverse health insurance offerings, retirement planning, and a global Employee Assistance Programme focused on well-being.
Matching Summary
The role involves providing expert knowledge on the technical development, testing, and manufacturing of various drug modalities including biologics and gene therapies.
Salary
Not specified; Competitive within each country; Range of additional benefits included
Skills & Requirements
Must-have
Expert knowledge in small and large molecules
Experience with Biologics, CGT, ADC, and Vaccines
Preparation of regulatory CMC submission documents
Management of INDs, NDAs, BLAs, and supplements
Technical development and manufacturing experience
Nice-to-have
Experience supporting business development activities
People management and team leadership skills
Certification in regulatory affairs (RAC)
Advanced degree in biological or medical fields
Ability to anticipate alternative regulatory strategies
Key Requirements
Bachelor's degree in life sciences or healthcare field
Relevant pharmaceutical and biologics regulatory experience
Global regulatory environment experience (US, EU, Canada)