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27 days old

Regulatory Affairs Manager

Kelly Services
Foster City, CA 94404
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 Manager** 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 Manager**



**Pay: $73 per hour depending on experience**



**Responsibilities**

Responsible for preparing and submitting moderately complex regulatory documents which require extensive interactions with departments outside of Regulatory Affairs for maintenance of products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include safety reports, protocol and information amendments, new investigator amendments, responses to health authority requests for information, labeling supplements and NDA annual reports

Contributes to the development and Regulatory review of documents required for maintenance of products in assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include aggregate safety reports (e.g. PSUR, DSUR, etc), clinical protocols, clinical study reports, investigator brochures, Module 2 documents, US labeling documents and other product-related documents

Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements

May serve as primary contact with local Regulatory Authority responsible for ensuring IND and NDA applications are updated and maintained in accordance with FDA requirements

May serve as Regulatory representative on Regulatory Project Team, Regulatory Submission Teams, study management teams, clinical teams and other subteams

Participates in group meetings and local and global product submission team meetings and presents project status updates and strategy approaches to moderately complex programs/projects

May provide regulatory expertise to submission teams on specified projects and topics

Initiates or contributes to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments

Knowledge and Skills

Knowledge and understanding of US regulations and guidelines.

Previous experience in the preparation and submission of clinical/non-clinical regulatory documents in support of US IND and NDA

Experience with marketed products is a plus

Excellent organizational, computer and documentation skills and an ability to prioritize effectively with tight timelines

Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment

Ability to work in a cross-functional team environment and project teams

Strong attention to detail and the ability to handle multiple tasks

Demonstrates capability to act as primary Company contact with Regulatory Authorities

Work is performed under minimal direction of a senior Regulatory Affairs professional


Education and Experience

5+ years of experience in Regulatory Affairs or other relevant industry experience

Degree in a scientific field is preferred



A. Will consider remote candidate

B. One year contract

C. There will be an initial phone screen, then a face to face or Skype

1. Candidate MUST have ability to work as Global and Regional Regulatory Leak

2. US Regulatory knowledge - major market request to be processed

EXPERIENCE

1. Small molecules and biologic ACTUAL experience

2. Medical device experience will be considered if they have at some point had small molecules and biologic experience

3. 4 YEAR BACHELOR SCIENTIFIC DEGREE





**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://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, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-12-23 Expires: 2020-01-23

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Regulatory Affairs Manager

Kelly Services
Foster City, CA 94404

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