OverviewThe Regulatory Submissions Specialist is responsible for the paper and electronic compilation and submission of Regulatory submissions and maintaining submission information in the proper RA repositories. The Regulatory Submissions Specialist will assist the regulatory affairs personnel for ensuring all publishing and QC processes are followed and all submission requirements are met prior to dispatching or submitting to the Health Authority.
Responsibilities- Work with regulatory staff to prepare, assemble, process, format, quality control, publish, submit and archive submissions (e.g., IND, CTA, BLA, Amendments, Supplements, Annual Reports, IMPD and Briefing Documents) to US, CA and other international health authorities using advanced electronic publishing software (eCTD Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions.
- Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission readiness and compliance
- Generate regulatory submissions on time and in compliance with Company standards and regional regulatory agency regulations.
- Assist with troubleshooting system issues
- Assist with developing best practices in submission publishing and enhancing process efficiency
- Archive documents according to archiving and document retention regulations
Qualifications- A minimum of 1 year of regulatory affairs electronic publishing experience preferred; other relevant experience with clinical trial documentation and electronic systems will be considered.
- Experience with IND, CTA, BLA submissions
- eCTD paperless submission experience using agency electronic submission's gateway (ESG)
- Experience preparing and submitting regulatory filings using Veeva RIMS
- Proficient in MS Word formatting large documents and using template
- EndNotes software experience a plus
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
- Demonstrated ability in analytical reasoning and critical thinking skills
- Ability to work in a fast paced environment and to handle multiple tasks
- Capability to contribute to a team environment
- Strong communication skills
- The ability to work independently and as part of a team
- Knowledge of publishing tools/systems in Pharma industry
Compensation StatementThe expected base salary for this position is: $76374.00 to $99188.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
