Regulatory Affairs Associate (local candidates only, Job at The Fountain Group, Irvine, CA

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  • The Fountain Group
  • Irvine, CA

Job Description

100% ONSITE IN IRVINE CA MUST BE LOCAL CANDIDATE, NO RELOCATION CANDIDATES

PAY: $35-$38

REQUIRED:

MS degree in a scientific field, plus one year (or co-op/internship) experience in regulatory affairs; or equivalent relevant work experience.

Packaging and label review

US and Canada regs

Submissions experience with project lifecycle

Notes:

  • Good regulatory foundation needs a regulatory mindset, does not need skincare experience
  • Pharma or medical device experience will work
  • Packaging and Labeling review would be a really nice to have, will need some sort of label review
  • US and Canada experience would be great.
  • Project lifecycle experience is ideal, submissions experience a huge plus.
  • Will work directly with their safety teams developing the labels and packaging
  • Hybrid, will need to be onsite for big project meetings, but 2-3 days remote ok
  • The years of experience with degree below is accurate, science related
  • BS degree in a scientific field, plus two years’ experience in regulatory affairs; or equivalent relevant work experience.
  • MS degree in a scientific field, plus one year experience in regulatory affairs; or equivalent relevant work experience.

• Basic knowledge of personal care product industry regulatory affairs discipline throughout the product lifecycle including development, commercialization and operations.

• Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.

• Ability to manage multiple priorities and projects with strict deadlines

• Working knowledge of the OTC drug monographs and cosmetics.

• Detail-oriented with the ability to proofread and check documents for accuracy and consistency.

• Excellent communication skills.

• Strong interpersonal skills with the ability to influence others in a positive and effective manner.

• Ability to understand and apply business drivers outside of Regulatory Affairs.

Job Tags

Work experience placement, Local area, Remote job, Relocation,

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