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| About our client |
| Our client is a privately owned biopharmaceutical company headquartered in Los Angeles that is dedicated to the development and commercialization of protein and antibody-based therapeutics for the treatment of various diseases. They have an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. |
| Position |
Location |
| Senior Manager/Associate Director of Regulatory Affairs |
Los Angeles, California |
| Salary |
Reports to |
| Highly competitive package, commensurate with experience |
Management |
| Responsibilities |
1) Prepare, implement and coordinate regulatory projects, plans and schedules with project team members (clinical, pre-clinical, manufacturing and business development) for the biologic products proposed for various indications
2) Work on projects, which center around pre-IND, IND, Phase I and Phase II activities
3) Contribute significantly to the development and implementation of regulatory strategy for multiple projects complementing the CMC, commercial, operational and clinical strategies for the product
4) Represent Regulatory Affairs on Pre-clinical, Clinical and Project Teams
5) Interact with the responsible departments
6) Manage the preparation and submission of regulatory documentation to FDA and international health authorities
7) Review the supporting documentation required for inclusion in regulatory submission
8) Ensure the quality, content and format of regulatory submissions (for communication/teamwork with project team members and development partners) |
| Requirements |
1) BS or MS in a scientific discipline or equivalent experience
2) Minimum 6 years of experience in the biotechnology/pharmaceutical industry
3) 4+ years of experience in a senior regulatory affairs management role preferred
4) Experience as a Lead RA person in IND and NDA submissions (preferred)
5) Knowledge of international regulatory guidelines
6) Experience in biological products
7) Knowledge of FDA regulations and direct liaison experience with FDA
8) Experience in oncology or inflammatory preferred
9) Strong knowledge of GCP and GMP requirements
10) Exceptional communication skills and multi-tasking abilities |
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