Regulatory Affairs Lightning Rod (RA Manager / Sr Associate)

ABOUT USManagement Recruiters International Inc. (MRINetwork) is the world's largest executive search and recruitment organization with a global network of more than 1,100 offices and 4,500 recruiting professionals. Founded in 1966 and consisting of five offices across New England, The Boston Group is MRI’s oldest, largest, and most highly acclaimed member. COMPANY INFOBe a key member of the team that is working diligently to conquer what most people fear the most – cancer and cancer treatment. Our Client’s goal is to develop innovative treatments for patients who face limited treatment options.  The Client has five product candidates in the clinical development process and is seeking motivated people with exceptional judgment who want to positively affect the lives of people who are touched by cancer, while growing personally and professionally with this special company.  If you’re interested in joining a company where you will be challenged and inspired daily, consider their REGULATORY AFFAIRS LIGHTNING ROD (aka Regulatory Affairs Manager/Senior Associate) position as the next step in your career development!  Reporting to the Director, Regulatory Affairs, your responsibilities will include management of regulatory document package submissions, license applications and annual registrations. Are you up to the challenge? The REGULATORY AFFAIRS LIGHTNING ROD will:  Coordinate, prepare and review document packages for regulatory submissions to the FDA and other government agencies, as well as license applications and annual registrations.  Work will be 60% CMC 40% clinical applications Research regulatory issues and review clinical, manufacturing and other documentation for regulatory compliance Ensure that regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability Maintain currency with additions/changes to regulations and guide-lines and evaluate relevance to company and product interests Identify and develop regulatory systems and/or procedures that would improve regulatory productivity Maintain departmental SOPs and databases and perform electronic publishing of submissionsThe REGULATORY AFFAIRS LIGHTNING ROD will have: A BA or BS in Life Science, Engineering, or JD 5+ years regulatory experience Knowledge of  global regulatory guidelines Previous experience in IND/BLA/MAA/CMC applications Biologic regulatory affairs experience (highly desired) Excellent organizational and communication skills and a flexible team-oriented attitude Strong attention to detail and the ability to handle multiple tasks Previous experience in electronic publishing software (highly desired)Demonstrated leadership ability A greater Boston Area address (highly desired) Out of the area Superstars will be consideredKey Words: BA/BS/JD, IND BLA MAA CMC biologic, regulatory affairs, Boston Area Qualified candidates send “Wordâ€� resume to jkroehler@mri-boston.com .  Due to the large volume of resumes received only candidates with specific qualifications requested by our client will be contacted.    MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Lexington, MA 02421 JOB CATEGORY: Legal TYPE: Full Time, Employee SALARY: 70,000.00 - 105,000.00 USD /year JOB REFCODE: RAMgr_N2042_JJK COMPANY: MRINetwork EMAIL: Apply by Email