Senior Manager CMC Regulatory Affairs

EPM Scientific
Oct 04, 2016
Oct 26, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Job Description:

Senior Manager, Regulatory Affairs CMC Location: Tarrytown, NY Salary: $110,000-$160,000 + bonus + excellent benefits A tier one pharmaceuticals firm is looking to add a Regulatory Affairs Manager for CMC to its rapidly expanding organization. This person will be responsible for the development of current team members as well as leading the strategic direction of the group. A number of hires must be made over the next six months but these will only happen after this key hire is made as the successful candidate will be heavily involved in the hiring process. This role will also include strategy development, risk and regulatory analysis, and communicating project details across multiple groups. The firm are seen as one of the top publicly traded pharmaceuticals firm and their share price is constantly increasing. They have recently won a number of awards for their work and this hire is necessary due to the expansion of the group due to their success across 2015. The aim of this hire is to continue this expansion and success across 2016/2017 following plan set out by the business leaders. The ideal candidate will have the following responsibilities: Previous experience in Regulatory Strategy for Product Lines as well as CMC Regulatory Filing projects individually Act as a liaison between internal teams and health authorities Provide regulatory CMC product strategy and support on submissions Preparation of Regulatory Submission documentationNew applicationsRenewalsSupplementsVariations Approval of manufacturing change requests Development of CMC Regulatory Strategy in accordance of combination Bio Pharma Products Qualifications: Bachelor's degree Minimum 4 years of experience in a regulated industry (pharmaceutical, biotech and/or medical device products). 3-5 years in quality systems or cross-functional project management. Experience working in a complex and matrix environment. Preferred: Relevant advanced degree preferred (MS, PhD, PharmD). Minimum 5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (e.g. RAC from the Regulatory Affairs Professionals Society.)

Company Description:

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. As an industry expert we understand that the ongoing changes within the Life Sciences industry make the ability to attract and maintain industry-leading talent a key priority.

As of today EPM Scientific has consultants based all over the world, from our own fully licensed and compliant offices in London, Zurich, Singapore, Hong Kong, New York, and San Francisco. Unlike many other companies, we have grown organically.