AstraZeneca Pharmaceuticals LP Director, Regulatory Affairs - CMC in Gaithersburg, Maryland

Director, Regulatory Affairs - CMC

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Director, Regulatory Affairs CMC in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

The Regulatory Affairs - CMC (Chemistry, Manufacturing & Control) group sits within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organization and is accountable for delivering CMC regulatory strategy as well as operational and tactical expertise for biologic drug projects. This specific position has a focus on post-approval variations and submission of global marketing applications.

Main Duties and Responsibilities

As a Regulatory Affairs Director you will be responsible for leading CMC regulatory strategy development and implementation that incorporates risk identification and contingency planning for assigned post-approval and global marketing authorization applications for biologic products (particularly monoclonal antibodies). You will be a key leader in interactions with Health Authorities, as necessary, to support CMC post-marketing activities. This role will actively partner with our Manufacturing Operations group to establish alignment of product regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally. You will be a Regulatory Affairs representative on various operations led teams as well as being responsible for the delivery of CMC post-marketing submissions and global marketing applications, ensuring that they meet current regulatory standards, are of high quality, consistent, complete, and approvable in the first review cycle.

You will partner with Regulatory Affairs therapeutic leads to ensure alignment of strategy for a variety of monoclonal antibody and therapeutic protein programs. You will participate on due diligence teams as necessary. You will coordinate and deliver CMC regulatory sections for submission to Health Authorities. You will participate and/or lead various multi-disciplinary teams or taskforces related to CMC. You will lead interactions with FDA or other Health Authorities as they pertain to CMC. You will liaise with all relevant groups to ensure high quality CMC documentation is developed. You will be meeting with relevant individual/groups on a regular basis to provide input on major regulatory CMC submissions and CTD development. You will interact effectively with external business partners.

Essential Requirements

  • BS/MS or Ph.D. in a scientific discipline (Ph.D. preferred)

  • Experience working directly in Regulatory Affairs – CMC

  • Considerable experience and increasing documented success in a biopharmaceutical field specifically working on biotechnology based products

  • Post-marketing submission experience is required and global marketing application experience is preferred.

  • Advanced understanding of regulations and guidance governing the manufacture of biotechnology products, and regulatory expectations thereof, especially monoclonal antibodies

  • Experience speaking and coordinating external conferences and other external advocacy experience is preferred.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.