Director, Regulatory Affairs - (Gaithersburg, MD)
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 Director (Grade F) 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.
Main Duties and Responsibilities
We are currently seeking a Regulatory Affairs Director (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.
- 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.).
- Strong experience 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.
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.