Randstad Regulatory Affairs Manager in Newbury Park, California

Regulatory Affairs Manager

job details:

  • location:Newbury Park, CA

  • salary:$59.50 - $70 per hour

  • date posted:Wednesday, March 20, 2019

  • experience:5 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:28169

job description

Regulatory Affairs Manager

job summary:

Join this top Pharma company to grow your Regulatory Career.

location: Newbury Park, California

job type: Contract

salary: $59.50 - 70.00 per hour

work hours: 8 to 4

education: Bachelors

responsibilities:

  • 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.

skills: IND, NDA, FDA, Regulatory Affairs Operations, Regulatory Affairs Strategy

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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