Regulatory Affairs Director - Oncology R&D (The position will either be for a Regional or Global Lead)
Location: Cambridge, UK or Gaithersburg, US
Competitive salary & 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 integrity, even in the most difficult situations because we are committed to doing the right thing.
The Regulatory Affairs Director is 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 labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
We currently have multiple opportunities available for Regulatory Affairs Directors within our Oncology therapy area.
Regulatory Affairs Directors posses 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 desirable to being able to influence cross-functional discussions with Global Product Teams (GPT) and relevant stakeholders.
You will have the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products. You will also 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.
Responsibilities will include:
Ability to effectively deputise for TA VP/Regional VP in senior level interactions internally or externally.
You will lead complex non-drug projects (cross-functionally)
Accountability for the development and implementation 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.
You'll lead and developing a global regulatory strategy of increasing complexity that is reflective of applicable domestic and international requirements.Leading the planning and construction of the global dossier and core prescribing information. Conducting regulatory risk planning and mitigation.
Leading the development and implementation of innovative strategies of increasing complexity to maximize the likelihood of regulatory success.
You will serve as the single point of contact and Global Regulator Affairs (GRA) representative on Product Development Teams (PDT)/Global Product Teams (GPT).
Leading the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement. Thus ensuring that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures, also accountable for product maintenance, supply and compliance activities associated with marketed brands.
You will lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
You'll partner with marketing company and regional regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
Lead the regulatory staff working on complex products/projects to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
Have the ability to lead the development, communication and updates the Regulatory Strategy Document for assigned products/projects of increasing complexity. Ensure appropriate consultation and peer review.
Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise Global Product Teams (GPT) accordingly.
- 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.).
- Extensive 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.
- 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 regional or 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.
- Oncology therapy area knowledge, but is not essential.
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.