Regulatory Affairs Manager (CMC exp required) - Contract to hire for IDEAL candidate! (Lexington, MA

Seeking an experienced Regulatory Affairs Manager with strong CMC background. This will be a contract (possibly contract to hire position for ideal candidate) with a large company located in Lexington, MA.Job SummaryThe Manager, CMC Regulatory Affairs will develop and implement CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements. Primary role includes:'Maintaining up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations'Assisting with liaisons between the regulatory authorities and the company on CMC issues'Regulatory team member on development Project Teams and CMC Sub teamsResponsibilities'Provide assistance for liaisons with regulatory authorities for assigned projects in the area of Chemistry, Manufacturing and Controls'Collaborating with other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND's, CTA's. BLA's and NDS and amendments'Evaluation of manufacturing change controls, assessment of regulatory impact and supporting their implementation'Facilitating timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, maintaining regulatory compliance for marketed products Education & Experience Requirements'B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field'4 - 8 years of drug development and CMC regulatory strategy experience'Demonstrated regulatory experience with biologics products'Excellent interpersonal, communication, analytical and managerial skills. 'Ability to work successfully with cross-functional teams and influence appropriate plans and actions.'Strong attention to detail, establishing priorities, scheduling and meeting deadlines. 'Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. 'Ability to work independently, take initiative and complete tasks to deadlines. Click the 'Apply Now!' button to be considered for this great opportunity. Or, refer a friend and click 'E-mail this Job.' There is never an application fee.Kelly Scientific Resources® has grown into a $200 million global business as the scientific business unit of Kelly Services. Clinical Research is the clinical business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science pharmaceutical, biomedical, consumer products, environmental, medical device, petrochemical, and clinical research.With more than 2,600 company-owned and operated offices in 30 countries, Kelly provides an incredible opportunity to job seekers all over the globe. 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.To be considered for this great opportunity please reply to:Nancy UreñaKSR- Clinical ResearchClinical Recruiter- Servicing NJ, NY and MA140 Route 17 North, Suite 314 * Paramus * NJ * 07652(201) 261-7325 ext 207 / (201) 599-8470 (fax) urenang@kellyservices.com Learn more about company