Regulatory Affairs Director

The arena
AstraZeneca is a world leader in the pharmaceutical industry and at the forefront in pushing the boundaries of science to deliver life-changing medicines to patients. In AstraZeneca you will be part of a vibrant culture that values diversity and give people an opportunity to grow.

If you have an in-depth strategic experience in global regulatory affairs, this could be an opportunity to join a team of highly motivated and engaged colleagues. As a Regulatory Affairs Director you will play a highly influential role in driving innovative project strategies working in global and/or regional project teams. We are now looking to fill positions within several therapeutic areas; Respiratory, Inflammation, Infection and Vaccines, Cardiovascular and Metabolic diseases.

The Role
The Regulatory Affairs Director (RAD) is accountable 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, 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 and relevant stakeholders. Has the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products.

Core Accountabilities/Responsibilities:
Accountable for the development and implementation, at a regional or global level, of innovative regulatory strategies and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling.

Leads (GRL) the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, RA CMC as well as delivery & enablement, to ensure prioritized objectives are delivered to time and quality. Through the GRST, ensures that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.

Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional and/or Global Product Teams.
Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures. The GRL is also accountable for planning and construction of the global dossier and core prescribing information as well as product maintenance, supply and compliance activities associated with marketed brands.

Lead..................................................FOR FULL JOB DESCRIPTION AND TO APPLY, please visit www.astrazeneca.se/karriar