Manage, evaluate, and complete regulatory projects consistent with company goals
Plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC
Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc
Participate on project teams and provide expertise on regulatory matters
Develop and maintain current regulatory knowledge and advise management of significant developments. Ensure compliance with departmental requirements including maintenance of regulatory archive.
Work with external regulatory consultants/CROs as required

Requirements

5+ years’ related experience is required with a Bachelor's Degree
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
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
Knowledge/experience with regulatory requirements for other regions also desirable
Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
Excellent oral and written communications skills are a must as well as superior planning skills
The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

Benefits

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submissionsIND preparationNDA preparationCTDeCTDGMPGLPGCPregulatory dossier preparationregulatory compliance

Soft Skills

oral communicationwritten communicationplanningdetail-orientedself-starterentrepreneurial mindsetability to manage broad responsibilitiesteam collaborationexpertise in regulatory mattersadaptability