Manager/Sr. Associate of Regulatory and Compliance

 Job Category: Biotech/R&D/Science  Type: Full Time, Employee  Minimum Education: Bachelor's Degree Manager/Sr. Associate of Regulatory and Compliance Our client, located in the southern New England area, is a very successful and growing international supplier of Active Pharmaceutical Ingredients (APIs).  They are seeking a Manager of Regulatory and Compliance to support company international Regulatory and Compliance activities. Job Responsibilities: Responsible for contributing to global regulatory submissions such as Drug Master Files  (DMFs) Certificates of Suitability (COS), DMF amendments, annual reports, and supplements. Support the preparation and management of API technical packages submitted to customers Assist the Director of Regulatory in conducting routine GMP inspections and prepare for FDA inspections and customers GMP audits of international API suppliers. Assist the Director of Regulatory in responding to any deficiencies, such as 483 or other deficiencies, resulting from an inspection.Job Requirements: 2-5 years experience in Pharmaceutical Regulatory and Compliance. API experience and analytical laboratory experience are highly preferred. Working knowledge of Regulatory, GMP Compliance and FDA regulations and applicable laws. Ability to interact effectively with other business units including sales and R&DCompensation: $65-85,000.  Compensation commensurate with experience. Outstanding benefits package, annual target bonus, profit sharing      For confidential consideration, please forward your resume in a Word document to: bthornton@kleinhersh.com .  Visit www.kleinhersh.com to view other job opportunities available through our company.  Company: MRINetwork  Contact Name: Bill Thornton  Email: Apply by Email Klein Hersh International is your connection to the best and brightest people involved in the Life Sciences and Information Technology industries. We are immersed in all aspects of the drug lifecycle- touching everything from drug discovery through clinical trials, dealing with commercialization as well as regulatory affairs, outsourcing organizations, marketing and branding. Our IT Division is deeply entrenched in the Software segment of the business placing sales professionals to C level executives. We know the talent the market demands and can help your organization reach its hiring goals! As a global leader in the Pharmaceutical/Biotech arena and Information Technology, Klein Hersh International has years of deep industry expertise and a large thriving network of contacts. Let us put it to work for you! Whether your company needs a contract or permanent executive level solution, we can help! Please visit us at www.kleinhersh.com to learn more.................. MRINetwork is one of the world's largest recruitment organizations. Through our Accelerated RecruitmentT approach, we find and place Impact Players, those individuals who arrive faster, fit better and stay longer. Providing our clients immeasurable return on their hiring investment by bringing them the people who make a difference in their business every day. The combination of our global reach, industry expertise and streamlined methodology allows MRINetwork to match companies with their Impact Players - the right candidate for the right position. MRI is a registered trademark licensed to Management Recruiters International, Inc. An Equal Opportunity Company Each office is independently owned and operated.