- 10+ years’ experience in regulatory affairs in the pharma/biotech industry with first-hand involvement in preparing, maintaining, and managing INDs and NDAs.
- BA/BS degree in a science discipline or equivalent experience in related field required. Advanced degree preferred.
- In-depth knowledge of the drug development process and associated FDA/ICH regulations and guidelines for all phases of pharmaceutical/biotech development, commercialization, and post approval life cycle
- Experience with timely preparation of pre-approval and post-marketing submissions, with a proven track record of approvals.
- History of direct written and verbal interactions with FDA and other regulatory agencies
- Previous experience with managing and supervising staff and external consultants
- Ability to operate a motor vehicle
- Ability to travel via airplane
- Ability to sit for long periods of time
- Ability to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal.
- Reaching: Extending hand(s) and arm(s) in any direction.
- Standing: Remaining upright on the feet.
- Pushing: Using upper extremities to press against something with steady force in order to thrust
- Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position of up to 20 lbs. on occasion
- Ability to prepare and analyze data and figures
- Ability to understand, remember and apply oral and written instructions
- Ability to organize and prioritize own works schedule
- Ability to apply common sense in performing job
- Ability to understand and follow instructions
Accommodations for Applicants with Disabilities
Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email firstname.lastname@example.org or call 224-441-6867 for assistance.
For more information about your EEO rights as an applicant under the law, please click here.