Regulatory Affairs Associate
Hays

Job Info

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

• Participates in preparing moderately complex CMC regulatory submissions under direction of a senior Regulatory Affairs professional which require some interactions with other members in the Regulatory CMC department and technical teams as well as senior stakeholders for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.
• Works to develop and acquire required regulatory skills and basic CMC knowledge, with guidance from immediate supervisor.
• Assist with miscellaneous US RA CMC team-related administrative documentation/tracking and product maintenance activities.
• Performs workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to the Regulatory Affairs CMC department.
• Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.
• Work cross-functionally within a matrixed organization.
• Must work well under deadlines and have excellent attention to detail in alignment with project goals and regulatory submission timelines.

Skills & Requirements

• A Bachelor's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training and industry experience preferably in GMP environment with advanced degree
• Strong computer and organizational skills required. 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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