Regulatory Affairs Associate - II

03 May 2024

Vacancy expired!

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a

Regulatory Affairs Associate - II

Job Description:

Job Title: Regulatory Affairs Associate - II

Job Type: Contract

Job Location: Foster City, California

Work Schedule: On-site

Responsibilities:
  • Responsible for the preparation of moderately complex regulatory submissions which require interaction.
  • with departments outside of Regulatory Affairs CMC for investigational products and marketed products
  • for US in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug
  • Listing, review and ensure product packaging and associated information is updated and maintained.
  • in accordance with the product license.
  • Develop and maintain knowledge of regulatory requirements independently and with line manager.
  • Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.
  • Contribute to local process improvements, which have an impact on the working of the RA CMC function.
  • or other departments.
  • Work cross-functionally within a matrixed organization.
  • Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.
  • Must be capable of leading a small team in preparation of regional submissions.
  • Must work well under deadlines and have excellent attention to detail. Strong computer and organizational
  • skills required. Work is performed under limited direction of a senior Regulatory Affairs professional.
  • Excellent verbal and written communication skills and interpersonal skills are required.

Qualification:
  • A Bachelor’s Degree with a minimum of 5+ years of relevant training or industry experience in Biologics, preferably in a GMP environment.
  • OR a Master’s Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment.
  • Preferred Degree in a relevant scientific field.
  • Relevant Regulatory CMC submission experience. Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements.
  • Regulatory Affairs Certification (RAC) is a plus but not required.

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

  • ID: #49848740
  • State: California Fostercity 00000 Fostercity USA
  • City: Fostercity
  • Salary: $0 - $0
  • Job type: Contract
  • Showed: 2023-05-03
  • Deadline: 2023-06-19
  • Category: Et cetera