Regulatory Affairs Manager
- Employer
- Apex Life Sciences
- Location
- Thousand Oaks, California
- Start date
- Jan 29, 2019
View more
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Contract
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Job Details
Description:
- Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
- Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
- Develop regulatory submission strategies in agreement with defined product development objectives.
- Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects.
- Prepare and submit IND and NDA applications, as well as various amendments and supplements.
Qualifications:
- Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
- Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
- Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
Company
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities. We are proud to have earned Inavero's 2018 Best of Staffing® Client and Talent Awards for providing superior service to clients and job seekers. Visit www.apexlifesciences.com for more information.
Stock symbol: ASGN
Stock exchange: NYSE
Company info
- Website
- https://www.apexlifesciences.com/
- Location
-
4400 Cox Road, Suite 200
Glen Allen
VA
23060
US
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