Regulatory Affairs Associate
Hays

Job Info

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The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Biotechnology Company is seeking a Regulatory Affairs Associate in Foster City, CA.

Role Description

• Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational products for US, Asia and LATAM 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 ensuring 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.

Skills & Requirements

• Bachelor's Degree with a minimum of 6+ years of relevant training or industry experience preferably in a GMP environment, OR a Master's Degree with a minimum of 4+ years of relevant training or industry experience preferably in a GMP environment. Preferred Degree in a relevant scientific field. Relevant Regulatory CMC submission experience. Regulatory Affairs Certification (RAC).
• 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.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.
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This job has expired.