AstraZeneca Pharmaceuticals LP Director, Regulatory Affairs - CMC in Gaithersburg, Maryland
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. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
This position is within the Regulatory CMC group and will be responsible for leading CMC regulatory strategy development and implementation that incorporates risk identification and contingency planning for assigned pre-approval biotechnology based programs.
As a director, this person will be a key player in interactions with FDA as well as other Regulatory Agencies as necessary to support CMC activities for their assigned programs. Strong skills in regulatory strategy development with respect to Reg CMC are expected along with a solid understanding of current regulatory environment and expectations. Strong business relationship skills are essential as this role will actively partner with Development teams and Regulatory Affairs therapeutic area counterparts to establish alignment with the product regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally. The position is an ad-hoc member on the AZI Product Development Teams and the Global Project Teams. This position also will be responsible for the development of CMC related documents for IND/IMPD/CTA, and CTD submissions, ensuring that they meet current regulatory standards, are high quality, consistent, complete, and approvable on the first review cycle. Provide effective RA CMC representation on a variety of development product teams. Participate in outside meetings, forums, etc to ensure the latest thinking is applied to CMC strategies.
Major Duties and Responsibilities:
Strong skills in regulatory strategy development for major market commercial biologics applications - Take a leadership role in establishing product specific strategies to ensure successful development of CMC packages to support early development, registration and life cycle management. Strong understanding of current regulatory environment. Strong business relationship management experience. A drive to continuously improve processes and manage processes. Partner with Regulatory Affairs therapeutic leads to ensure alignment of strategy for a variety of monoclonal antibody programs. Participate on due diligence teams as necessary. Coordinate CMC regulatory sections for submission to Health Authorities. Participate and/or lead various multi-disciplinary teams or taskforces related to CMC. Lead interactions with FDA or other HA’s as they pertain to CMC. Liaise with all relevant groups to ensure high quality CMC documentation is developed Lead development of all major BLA and CTD submission elements relating to CMC and effectively communicate comments/recommendations and proactively engage teams to establish solutions to issues. Meets with relevant individual/groups on regular basis to provide input on major regulatory CMC submissions and CTD development Interact effectively with external business partners.
Education: BS/MS/PhD in a scientific discipline.
Experience: A minimum of 6 years of increasing documented success in biopharmaceutical field, with a minimum of 3-5 years in regulatory affairs biotechnology CMC. BLA/CTD submission experience a plus. Consideration will also be given to individuals who have worked for a regulatory agency in a biologics CMC review role with a minimum of 5 years of review experience.
Job Complexity: Strong understanding of regulations governing manufacture of biotechnology products, especially monoclonal antibodies for initial commercial applications in US, EU, Japan, and Canada; Application of critical thinking skills; Strong matrix management skills in order to fulfill a leadership role with both internal and external partners; Being pro-active and identifying issues early along with recommending and negotiation potential solutions.
Supervision: Independently accomplish routine work. Accomplish most new assignments with minimal supervision
Next Steps – Apply today!
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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.