US-IL, Regulatory Affairs Manager, CMC - Medical Device 452431245068-MZ
|Manager, Regulatory Affairs CMC - Combination Products & Medical Device|
Location: Chicago, IL
Salary: $110,000-$130,000 + bonus + excellent benefits
A tier one pharmaceuticals firm is looking to add a Regulatory Affairs Manager for CMC across Combination Products and Medical Devices. 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 2014. The aim of this hire is to continue this expansion and success across 2015/2016 following plan set out by the business leaders.
The ideal candidate will have the following responsibilities: · Previous experience in Regulatory Strategy for Combination Products as well as CMC and Medical Device 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 documentationo New applicationso Renewalso Supplementso Variations· Approval of manufacturing change requests· Development of CMC Regulatory Strategy in accordance of combination Medical Device Products
Qualifications:· Bachelor's degree· Minimum 4 years of experience in a regulated industry (pharmaceutical 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, JD).· Minimum 5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.· 3-5 years of experience at a regulatory agency, such as FDA, EMA or other national agency or experience at a Notified Body. · Certification is a plus (e.g. RAC from the Regulatory Affairs Professionals Society.)
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