Senior Regulatory Affairs Specialist
$140,000–$160,000 year
RemoteUnited States
Job Summary
Plan and manage regulatory authority submissions for IND, BLA, and NDA programs, including oversight of CROs and vendors for source document tracking. Independently prepare routine amendments such as Annual Reports, DSURs, Investigator Packages, and SUSARs while maintaining regulatory logs and correspondence with FDA. Represent Regulatory Affairs on cross-functional teams to support submission planning, briefing packages, and global health authority submissions in eCTD format. Prepare templates, compile presentations, and ensure high-quality document approval on schedule. Manage trackers for multiple products and adhere to ICH guidelines and regional requirements.
Required Qualifications
- BS degree
- Minimum 8 years' experience in regulatory affairs or a related function in drug/biologic development
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
- Must have visual acuity to perform activities such: preparing and analyzing data and figures, viewing a computer screen, and extensive reading
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers
- Must be able to communicate with others to exchange information
- Clear and conceptual thinking ability
- excellent judgment
- troubleshooting
- problem-solving
- analysis
- discretion
- ability to handle work-related stress
- ability to handle multiple priorities simultaneously
- ability to meet deadlines
Desired Qualifications
- advanced degree (PharmD, PhD, Master's)
- Strong scientific or research background, with a focus in pharmacy, chemistry, or biology
- Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus
- Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development
- familiarity with ICH and regional regulatory requirements
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro
- High attention to detail and accuracy
- High level of motivation and proactiveness required to engage in both in-person and remote team members
- Excellent interpersonal, verbal and written communication skills
- Ability to work independently with minimal supervision or direction
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
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