AstraZeneca

Regulatory Affairs Director

Gaithersburg, Maryland, United States of America · Director

Sponsorship not specified$179k-$268kDetected 1 day ago

FDA RegulatoryLeadershipCommunicationCritical ThinkingRegulatory Affairs

About the role

We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people's outstanding skills with those of people from all over the globe.
Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs.
We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.

Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.
Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success.
Lead preparation of the regulatory strategy document and target product labeling.
Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead.

Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
A solid knowledge of regulatory affairs withinoncology area in early and late development.
Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.

Advanced degree preferred.
Experience in Hematology is preferred.
Contribution to a regulatory approval including leading response team and labeling negotiations.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Ability to work strategically within a business critical and high-profile development program.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
Next Steps - Apply today!
AstraZeneca embraces diversity and equality of opportunity.

The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
Own the negotiations with health authorities and initiate and deliver key regulatory documents.

At AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing!

If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements

This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.