EXCLUSIVE and RETAINED SEARCH ARE YOU THE PERSON THAT BIOLOGIC CMC PROFESSIONALS THINK OF WHEN THEY NEED CMC EXPERTISE? THEN YOU WILL BE VERY INTERESTED IN THIS NEWLY CREATED POSITION TO BE THE MOST SENIOR LEVEL REGULATORY AFFAIRS CMC LEADER FOR A LEADING BIOLOGICS COMPANY!! IN ORDER TO BE CONSIDERED FOR THIS FANTASTIC OPPORTUNITY YOU MUST HAVE THE FOLLOWING:
DEPARTMENT AND LEADING THE CMC GROUP
Regulatory Affairs Chemistry, Manufacturing & Controls (CMC) will direct the RA CMC organization and be responsible for global CMC regulatory strategy and support for all biological products. This position reports to the SVP, Global Regulatory Affairs and will be a member of the Regulatory Affairs Leadership Team. Major Duties and Responsibilities:
Development Teams (PDT’s), CMC Development Teams, Commercial Brand Teams, Research, Clinical, Operations and Quality Teams, which includes both approved products and those under development across the company’s biologics portfolio. • Collaborate as a trusted peer with the VP’s of CMC Development, Research, Clinical, Manufacturing Quality Assurance and Quality Control to establish appropriate risk- based solutions which account for regulatory requirements. Work to integrate regulatory CMC requirements and expectations throughout the organization. • Develop high-level regulatory strategies for ensuring a harmonized approach for CMC submissions across a variety of therapeutic areas. • Ensure regulatory oversight and consistency associated with the review and evaluation of change controls, quality investigations, quality audits, change controls, etc., that may impact both domestic and international clinical trial applications and marketing dossiers. • Act as the company’s leading external regulatory CMC representative to PhRMA, BIO, and other key trade organizations. • Attend and present at applicable CMC-related conferences to drive company initiated policies and to maintain up-to-date knowledge of industry standards and regulatory authority expectations.
regulations, to members of assigned Project Teams in order to obtain rapid approval of CMC supplements and variations. • Provide guidance and oversight for the development of, the administrative and CMC sections of regulatory submissions including but not limited to IND/IMPD/ BLA/MAA/DMF/Site Master Files to US, EU and ROW regulatory agencies. • Review and determine the applicability, accuracy, and completeness of supporting documentation for inclusion in regulatory submissions. • Approve supporting CMC documentation for inclusion in regulatory submissions. • Provide critical support for regulatory CMC planning and global manufacturing expansion, to conclude with successful and timely approvals of new sites and processes for all products, thus assuring maintenance of market supply. • Leveraging Manufacturing QA and GXP Compliance, ensure corporate and partner adherence to, and compliance with, established company policies, practices, SOP’s, and applicable US, EU and ROW regulations as they relate to CMC. • Serve as an effective liaison with Worldwide Company Partners on regulatory CMC matters to ensure the needs of the regulatory agencies, Partners, and Company are met. • Educate internal stakeholders on intent and implications of CMC-specific regulations and guidance.
IF YOU QUALIFY AND WANT MORE INFORMATION, SEND YOUR RESUME TO: sue.komers@eliteresourcesolutions.com. I WILL CONTACT YOU AND WILL SEND YOU THE JOB DESCRIPTION AND WILL GIVE YOU ALL THE DETAILS ABOUT THIS WONDERFUL COMPANY AND THIS INCREDIBLE OPPORTUNITY. We will never send your resume anywhere without your permission. RETURN TO CURRENT OPPORTUNITIES PAGE |
Vice President, CMC Regulatory Affairs, Biologics #9170
Elite Resource Solutions, LLC
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