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 . 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.