Regulatory Affairs Associate (A) Job in North Chicago, Illinois US
Regulatory Affairs Associate (A)
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a high-level contract opportunity for a Regulatory Affairs Associate for our client in North Chicago, IL. As a Regulatory Affairs Associate, you will be responsible for product registrations and submissions, which includes: Identifying/obtaining data needed and ensuring that it is effectively presented for the registration of products Assessing scientific data provided by specialist units for registration purposes against regulatory requirements Managing preparation of registration packages (including complex) and answering to deficiency letters Ensuring records of filings and approvals are maintained Approving the complete regulatory data packages prior to filing and during the approval process Preparing agency meeting packages and developing strategies for agency meetings The Regulatory Affairs Associate will also have a function relating to relationships and cross-functional teamwork. This involves: Representing Regulatory Affairs at relevant meetings (i.e. Brand Team, Product Workstream, CMC Workstream, etc.) and presenting agreed RA position Negotiating with and influencing management (i.e. Manufacturing, Quality, Development, Commercial, etc.) to ensure programs meet regulatory requirements Monitoring actual versus planned activities and timelines Identifying issues impacting project progression Participating in agency meetings, as appropriate Training, developing and mentoring individuals; may include formal supervisory responsibilities This individual will also be involved in strategy and advising business partners, such as Commercial, Development, QA, Manufacturing, and New Business Development on global regulatory requirements. He/She will define regulatory strategies for the registration of products, facilitate policy development and standard interpretation of regulations and provide regulatory expertise to licensing departments. Process improvement duties will include identifying and implementing process improvements, implementing position papers and work aids as well as identifying opportunities for business and efficiency improvements. EDUCATION/EXPERIENCE Qualified candidates should have a Bachelor?s degree in Pharmacy, Biology, Chemistry, Pharmacology, or related area. A Master?s degree is preferred. In addition, candidates should have 7 years in RD or related area, ideally including 5 years in a Regulatory environment. Candidates with previous CMC experience will be given preference. If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted. Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.