Senior Associate Regulatory Affairs
I am currently working with an advanced oncolytic immunotherapy company working to improve on existing therapies. Helping them seek a motivated Regulatory Affairs Senior Associate, my client is targeting a candidate dependable, hardworking candidate, with 2 years of industry experience who can participate and ensure Regulatory Submission (IND, CTA, BLA etc.) to the FDA and other necessary Regulatory agencies. If you are seeking a Senior Associate Regulatory Affairs position with a strong drive to enhance your skillsets, overall industry experience and be a key member on the Regulatory team- now is the time to apply!
In this role you will be responsible for:
- Help prepare documentation packages for regulatory submissions (including IND, CTA, etc.) to the FDA and other regulatory agencies.
- Maintain regulatory documentation requirements- including submissions to and correspondence with all Regulatory Authorities
- Format, edit, coordinate and review regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions.
- Compile documentation for submissions to FDA and foreign regulatory agencies.
- Maintain Regulatory Affairs product filings, ensuring regulatory compliance
The client requires that all candidates have:
- A or B.S. degree in an appropriate scientific or other related field
- 3-6 years of pharmaceutical/Biotechnology experience
- 2 years* experience working in Regulatory Affairs
- Previous participation in preparing regulatory submissions (IND, CTA, BLA, etc.) to the FDA and EU Regulatory Authorities (Global Regulatory experience_
- Strong understating of CTD/eCTD and CDER requirements