Senior Manager, Regulatory Affairs
$139,800–$184,800 year
RemoteUnited States
United StatesRemoteFull Time$139,800–$184,800 yearSenior LevelBachelors DegreeLarge
Full TimeSenior LevelBachelors DegreeLarge
Job Summary
Plan and manage regulatory activities for assigned projects spanning clinical, non-clinical, and CMC areas. Lead authoring and preparation of annual reports, safety reports, and regulatory submissions including INDs, NDAs, and amendments. Manage the assembly, review, and timely submission of regulatory dossiers for product registration in the US and abroad. Represent Regulatory Affairs on cross-functional project teams and provide guidance on regulatory strategy and tactics. Ensure submissions maintain compliance with FDA, ICH, GMP, GLP, and GCP requirements while maintaining the regulatory archive.
Required Qualifications
- 7+ years' related experience
- BA/BS degree
- Experience and knowledge in preparation of INDs
- Experience with CTD/eCTD
- Working knowledge of FDA and ICH regulatory guidance and regulations
- Understanding of FDA structure and function
- 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
- Experience and knowledge in preparation of NDAs
- Experience with supportive amendments and supplements (manufacturing, nonclinical, clinical)
- Experience with publishing documents in Adobe Acrobat Professional
- Knowledge/experience with regulatory requirements for other regions
- Working knowledge of GMP, GLP, and GCP regulations
- Understanding of the pharmaceutical product life cycle
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