Senior Director Regulatory Affairs - Oncology
Location: Cambridge, UK
Competitive salary and benefits
Closing Date: 10th January 2020
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.
The Senior Director Regulatory Affairs, Oncology is accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
In this role, you will possess 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 programmes.
Responsibilities, what you will be doing:
You will have experience and knowledge of the oncology disease area, which is critical to being able to influence cross-functional discussions with the Global Product Teams (GPT) and relevant stakeholders.
You'll take on the Global Regulatory Lead (GRL) role for a product/group of products and will have the ability to function in dual capacity by delivering the overarching global regulatory strategy as well as serve as a regional lead based on their location, respectively.
You will lead the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, CMA as well as delivery & enablement. You will thus ensure that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy which in turns contributes to the Global Product Development Plan.
You'll be accountable for product maintenance, supply and compliance activities associated with marketed brands.
You will monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise Global Product Teams accordingly.
You will provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- 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.).
- Oncology therapy area knowledge and experience
- Extensive experience of regulatory drug development including product approval/launch.
- 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.
- Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
Should you be interested in this role, please apply by submitting your CV. Thank you.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.