Regulatory Affairs Associate

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Regulatory Affairs Associate at a prestigious Fortune 500® company working in Foster City. 

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.

 

Job Title: Regulatory Affairs Associate

 

Pay: $33 per hour

 

Responsibilities
- Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.
- Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.
- May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department
- Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
- Seeks assistance from appropriate internal and external resources.

Knowledge and Skills
- Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.
- Strong verbal and written communication skills and interpersonal skills.
- Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- Proficiency in Microsoft Word and Excel.
- Experience with Microsoft Power Point, Project and Visio a plus.
- Act as a resource on limited topics within the department.
- Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.

Education and Experience
- 4+ years of relevant training or industry experience with BS/BA.
- 3+ years relevant training or industry experience with advanced degree.
- Degree in a scientific field is preferred.

 

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

 

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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