Demo

Regulatory Affairs

Manpower San Diego
San Diego, CA Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/16/2025

Job Title : Regulatory Affairs – Contractor

Location : Remote

Schedule : Monday – Friday, 8 : 00 AM – 5 : 00 PM PST

Duration : 6 months

Pay : $82.00 per hour

Do you take pride in the work you do and continuously strive to achieve more? Here, you will make a meaningful impact. We seek talented individuals who are ready to take on complex challenges, think beyond the ordinary, and contribute to advancing our mission. Join us as a Regulatory Affairs Contractor , where you’ll be part of a diverse, collaborative team dedicated to delivering impactful innovations that improve lives.

How You’ll Make a Difference

As a Regulatory Affairs contractor, you will support the creation and implementation of global regulatory CMC strategies for both marketed and developmental products. Working closely with internal and external teams, you will help ensure seamless regulatory compliance, timely submissions, and successful approvals of global filings.

Key Responsibilities

  • Review and assist with the preparation of regulatory submission documents.
  • Provide well-reasoned regulatory guidance to cross-functional teams by interpreting relevant regulations.
  • Contribute to preparing materials for health authority meetings and address information requests.
  • Research, create, and present on global regulatory topics to internal teams and external partners.
  • Ensure regulatory compliance, including managing regulatory changes.

What You’ll Need to Succeed

  • A bachelor’s degree in science (or equivalent experience) and at least three years of experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry.
  • Practical knowledge of FDA / EMA regulations and experience with Health Authority submissions.
  • Strong communication, writing, and analytical skills.
  • Familiarity with European / global submissions and regulatory management of commercial products is a plus.
  • What We Offer

  • Flexible hybrid work options.
  • A collaborative and innovative environment that fosters teamwork and supports your professional growth.
  • We are committed to providing equal opportunities to all qualified candidates, regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, veteran status, disability, or genetic information.

    Salary : $82

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