Senior Regulatory Affairs Director (Vaccines & Immune Therapies) job opportunity at AstraZeneca.

Home Jobs In United States Of America Tag: Job Senior Regulatory Affairs Director (Vaccines & Immune Therapies) position at AstraZeneca


DatePosted 30+ Days Ago bot
AstraZeneca Senior Regulatory Affairs Director (Vaccines & Immune Therapies)
Experience: 10-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation US - Gaithersburg - MD, United States Of America
loacation US - Gaithersb..........United States Of America

AstraZeneca - Vaccines & Immune Therapies   At AstraZeneca, we   are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played   an important role   as part of a truly global effort to respond to a new and unprecedented challenge.   We will continue to advance science in vaccines and immune therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people.     Role     The   Senior   Regulatory Affairs Director   (SRAD)   leads the global regulatory strategy for complex products. They aim to secure rapid approval that meets business, market, and patient needs. The   SRAD   offers strategic leadership and has   expertise   in global regulatory science, drug development processes, and strategies for high-profile programs. Familiarity with the disease area is essential to influence cross-functional discussions with Global Product Teams (GPT) and stakeholders. They can serve as the Global Regulatory Lead (GRL) for a product group   and also   act as a regional lead based on their location .      Your strategic leadership skills and deep understanding of global regulatory science   from early to late-stage development into commercialisation strategy   will be crucial in influencing cross-functional discussions and guiding high-profile development programs , as well as interacting with Global Health   Authorities .   Are you prepared to take on the Global Regulatory Lead role and drive innovative strategies for regulatory success ?     Responsibilities   Effectively   lead or   deputise for T h erap e utic Area (T A )   VP/Regional VP in senior-level interactions internally or externally , including   contributions to   in ternal governance    Develop and implement regulatory strategies for products, ensuring rapid approval with   advantageous   labeling .   Lead the planning and construction of global dossiers and core prescribing information.   Conduct regulatory risk planning and mitigation.   Serve as the single point of contact and Global Regulatory Affairs representative on Product Development Teams.   Lead the Global Regulatory Sub-team   to ensure regional regulatory needs are incorporated into the Global Regulatory Strategy   and ensure execution on strategy .   Deliver all regulatory milestones, assess regulatory success probabilities, and implement risk mitigation measures.   Partner with marketing and regional regulatory affairs staff to   help   shape the   environment   and   Health   Authorities' views on relevant topics.   Lead regulatory staff on complex projects to ensure prioritized   objectives   are delivered on time and with quality.   Ensure effective regulatory representation at health authority meetings with clear documentation of discussions.   Lead the development and updates of the Regulatory Strategy Document for complex projects.   Monitor changes in the regulatory environment and   advise   Global Product Teams accordingly.   Provide regulatory leadership in product in-license/due diligence review, divestment, and withdrawal.   Lead complex projects designed to improve efficiencies and simplification, spanning cross functional areas.       Skills/Experience   Advanced degree in a science-related field and/or other   appropriate knowledge/experience .   At least 10   years experience   or equivalent of regulatory drug development including   s uccessful contribution to a major regulatory   approval   at a global level.   Experience in Infectious Diseases is strongly preferred .   Must have   previous   experience in leading Major Health Authority interactions (e.g., FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc .).   Proven leadership and program management experience , as well as the a bility to think strategically and critically evaluate risks to regulatory activities.   Ability to work strategically within a complex, business-critical and high-profile development program.     Why AstraZeneca?   At AstraZeneca   we’re   dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.   There’s   no better place to make a difference to medicine,   patients   and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning,   growth   and development.   We’re   on an exciting journey to pioneer the future of healthcare.   Competitive salary and benefits package on offer:   Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to   create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.   The annual base salary for this position ranges from $ 211,581.60 - 317,372.40 .   However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to   participate   in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage   in accordance with   the terms and conditions of the applicable plans.   Additional   details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to   modify   base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.    Date Posted 28-Jan-2026 Closing Date 27-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Other Ai Matches

Compliance Intern - Summer 2026 Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Group Internal Audit Applicants are expected to have a solid experience in handling Group Internal Audit related tasks
Finance Business Partner Applicants are expected to have a solid experience in handling Job related tasks
Snr. Director – Head of Digital Diagnostics Applicants are expected to have a solid experience in handling Job related tasks
Level 3 Engineering Maintenance Technician Apprentice Applicants are expected to have a solid experience in handling Job related tasks
Chef de Produit Sénior Oncologie (H/F) Applicants are expected to have a solid experience in handling Job related tasks
Pharmaceutical Sales Specialist, CVRM Primary Care - Fort Myers, FL Applicants are expected to have a solid experience in handling CVRM Primary Care - Fort Myers, FL related tasks
Senior Pharmaceutical Sales Specialist, Respiratory Specialty Care -Kansas City, MO Applicants are expected to have a solid experience in handling Respiratory Specialty Care -Kansas City, MO related tasks
MR-BC-郑州 Applicants are expected to have a solid experience in handling Job related tasks
Account Business Manager Linea Lung Applicants are expected to have a solid experience in handling Job related tasks
合作营销经理-Eagle-汉中 Applicants are expected to have a solid experience in handling Job related tasks
Clinical Research Associate, Oncology Applicants are expected to have a solid experience in handling Oncology related tasks
Biologics Engineering: Protein Engineering & Novel Modalities Intern Applicants are expected to have a solid experience in handling Job related tasks
Content Delivery Manager (CDM) CEEBA - GCS - Content & Omnichannel Applicants are expected to have a solid experience in handling Job related tasks
Associate Principal Scientist, Process Engineering – Global Product Development Applicants are expected to have a solid experience in handling Process Engineering – Global Product Development related tasks
Senior Scientist Integrated Bioanalysis – Immunoassay Specialist Applicants are expected to have a solid experience in handling Job related tasks
Regional Liaison Director – Immunology Field Medical Northeast Applicants are expected to have a solid experience in handling Job related tasks
Directeur Régional CVRM - Bretagne (H/F) Applicants are expected to have a solid experience in handling Job related tasks
Clinical Regulatory Writer, Associate Director Applicants are expected to have a solid experience in handling Associate Director related tasks
MR-BC-成都 Applicants are expected to have a solid experience in handling Job related tasks
Senior Scientist – Oncology Targeted Discovery (Drug Conjugates) Applicants are expected to have a solid experience in handling Job related tasks
ADC Sr. Brand Manager Applicants are expected to have a solid experience in handling Job related tasks
SMM/AD-CVRM MKT-上海 Applicants are expected to have a solid experience in handling Job related tasks