Detail

Salary
negotiable
Location
Gaithersburg, MD, USA
Posted by: Astra Zeneca
14 Oct
48 Views
13 Dec expires

Regulatory Affairs Director- Oncology

Gaithersburg, MD, USA
Job Description

We are currently seeking multiple Regulatory Affairs Directors (RAD) to join our Global Regulatory Affairs team.  As the Regulatory Affairs Director, you will be accountable for the development and implementation of the regulatory strategy for a product or group of products and for ensuring that the strategy is designed to deliver a 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 Director possesses strategic leadership skills, has an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams (GPT), Investigational Product Teams (IPT) and relevant stakeholders.  The Regulatory Affairs Director has the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products.

As the Regulatory Affairs Director, additional duties include accountability for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business and patients, leading and developing a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements, leading  the planning and construction of the global dossier and core prescribing information and leading the development and implementation of innovative strategies to maximize the likelihood of regulatory success.

Job ID Reference
1408
Desired Skills & Experience
  • Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
  • 5 to 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.
  • 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.
  • 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 or regional 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.
Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Gaithersburg, MD, USA