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 Regulatory Affairs Senior Director / Group Manager, Oncology in Gaithersburg, Maryland 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.
AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
Main Duties and Responsibilities
We are currently seeking a Regulatory Affairs Senior Director / Group Manager to join our Global Regulatory Affairs team. As the Regulatory Affairs Senior Director / Group Manager you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity and for ensuring that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The Regulatory Affairs Senior Director / Group Manager will set clear direction for the regulatory staff reporting to them and will lead, manage, mentor and coach Regulatory Affairs Director’s (RADs) within the therapeutic area.
As the Regulatory Affairs Senior Director / Group Manager you will possesses strategic leadership skills, have a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs. Experience and knowledge of the disease area is critical to being able to influence cross-functional discussions with Global Product Teams (GPT) and relevant stakeholders.
- Advanced degree in a science related field and/or other appropriate knowledge/experience.
- 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.).
- >10 years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas - Oncology
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Experience in relevant therapy area (small molecules & biologics) is preferred.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business critical and high profile development program.
- Successful contribution to a major regulatory approval at a global level.
- A scientific and clinical understanding of the regulatory sciences.
- Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.