Sr Associate Regulatory Affairs
at Ronin Staffing

Date Posted: 9/6/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title:
Sr Associate Regulatory Affairs 
Pay: $38.00/hr
Location: Thousand Oaks, CA 91320
Duration: 1 year contract with possible extension                       

Description:

The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle. Support may include organizing, managing and executing on regulatory CMC projects and submissions. Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.

Ideal candidate has:

  • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project
  • Strong organizational skills with attention to detail
  • Excellent time management skills and ability prioritize workload
  • Project management skills
  • Adept interpersonal and communication skills (both verbal and written)
  • Ability to work both independently and as a member of a team

Years of Experience

  • Master’s degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

OR

  • Bachelor’s degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

OR

  • Associate’s degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

OR

  • High school diploma / GED and 8 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience

Preferred Qualifications

  • Degree in life sciences, biochemistry, or chemistry
  • Experience in biopharmaceutical or pharmaceutical industry
  • Familiarity with eCTD structure
  • Motivated with initiative to learn quickly
  • Experience in CMC, including preparation of submissions to Agencies

Useful Information for Candidate

  • Contract is for one year with potential to extend to up to additional 2 years. This junior level position is considered a “ramp” to potential full-time employment.

Top Must Have Skill Set:

  • Strong organizational skills with attention to detail;
  • Excellent time management skills and ability prioritize workload;
  • Ability to work both independently and as a member of a team.

Day to Day Responsibilities:

  • Organizing, managing and executing on regulatory CMC projects
  • Creating and/or maintaining timelines and tables of contents
  • Formatting of documents per style guide
  • Scheduling meetings
  • Drafting meeting agendas and minutes

Job Snapshot

  • Employee Type: Contractor
  • Location: Thousand Oaks, CA
  • Job Type: Other
  • Experience: Not Specified
  • Date Posted: 9/6/2019

About Us

Founded in 1999 as a woman- and minority-owned IT staffing organization, Ronin Staffing has grown into a full-service staffing search firm that recruits and places qualified and quality candidates with expertise in a wide range of areas, including Engineering, Aerospace, Administration, Accounting/Financing, to name a few. We offer contract-only, contract-to-hire or direct-hire services to our clients and our contractors alike.

Our team of experienced, dynamic and tenacious recruiting specialists will provide you with the personal assistance you need to keep your career moving onward and upward. Whether you are looking for hourly, mid-management or executive level positions, you can be confident in our recruiters’ ability to match you with just the right assignments with just the right companies to suit your needs. Many members of our staff have backgrounds in the industries for which they now recruit, and Ronin has become one of the leaders in providing professionals to Fortune 100, 500, and 1000 companies.

We are proud to offer you a full line of services to help you to meet your career objectives, including resume assistance, human resources consulting, and expert guidance on professional interviewing techniques. We also offer direct deposit and a competitive benefits package.

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