Senior Associate, US Regulatory Affairs
$93,600–$123,600 year
RemoteUnited States
United StatesRemoteFull Time$93,600–$123,600 yearSenior LevelLarge
Full TimeSenior LevelLarge
Job Summary
Manage regulatory activities for assigned projects spanning clinical, non-clinical, and CMC areas with minimal supervision. Plan and coordinate regulatory submissions, including INDs, NDAs, supplements, and annual reports, ensuring compliance with FDA and ICH requirements. Author, review, and submit regulatory dossiers while maintaining the regulatory archive and supporting cross-functional teams on strategy and tactics. Work with external consultants and CROs as needed to expedite approvals and provide expertise on significant regulatory developments.
Required Qualifications
- BA / BS in Health Science
- at least 2+ years' experience in the pharmaceutical industry
- Experience and knowledge in preparation of INDs
- Experience with CTD/eCTD
- Experience with publishing documents in Adobe Acrobat Professional
- Working knowledge of FDA and ICH regulatory guidance and regulations
- Understanding of FDA structure and function
- Working knowledge of GMP, GLP, and GCP regulations
- Understanding of the pharmaceutical product life cycle
- Excellent oral and written communications skills
- superior planning skills
- detail-oriented
- self-starter
- comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
Desired Qualifications
- BA / BS in Health Science, preferred
- Experience and knowledge in preparation of NDAs
- supportive amendments and supplements (manufacturing, nonclinical, clinical)
- Knowledge/experience with regulatory requirements for other regions
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