Regulatory Affairs Senior Director/Group Manager

AstraZeneca Göteborg / Läkarjobb / Mölndal
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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.

We are now looking to hire a Regulatory Affairs Senior Director /Group Manager

The role
The Regulatory Affairs Senior Director/Group Manager 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 labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This individual will set clear direction for the regulatory staff reporting to them and will lead, manage, mentor and coach RADs within the therapeutic area. The Regulatory Affairs Senior Director /Group Manager possesses strategic leadership skills, has 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 critical to being able to influence cross-functional discussions with Global Product Teams (GPT) and relevant stakeholders. Has the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products. Has the ability to function in multiple capacities by delivering the overarching global regulatory strategy, serve as a regional lead based on their location, respectively and lead manage, mentor and coach RADs within the therapeutic area.

Core Accountabilities/Responsibilities:
Line manages and provides leadership to a strategic regulatory team within the TA. Ensure the principles of performance management are used to develop staff to their full potential in addition to providing coaching, skill development performance feedback to other regulatory staff working on projects.
Ability to effectively deputise for TA VP/Regional VP in senior level interactions internally or externally
Ability lead budget management, resource planning and recruitment of staff in partnership with the Global TAVP as required. Together with the TAVP, advises on the appropriate deployment of GRL/RAD staff to Regulatory Project Teams ensuring the appropriate deployment of staff based on skills required and project prioritization. Regularly review such allocation to ensure optimum utilization and development of staff.
Ability to lead complex non-drug projects (cross-functional or cross-SET area)
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 and patients.
Leads and develops a global regulatory strategy of increasing complexity that is reflective of applicable domestic and international requirements.
Leads the......................................................FOR FULL JOB DESCRIPTION AND TO APPLY, please visit www.astrazeneca.se/karriar .

Varaktighet, arbetstid
Tillsvidare
Heltid

Publiceringsdatum
2016-06-10

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Sista dag att ansöka är 2016-06-26
Ange följande referens när du ansöker: GOT0000006W

Företag
AstraZeneca Göteborg

Adress
AstraZeneca Göteborg
43183 MÖLNDAL

Kontorsadress
PEPPAREDSLEDEN 1
MÖLNDAL

Övriga kontaktuppgifter
Telefonnummer: 031-7761000

Jobbnummer
2897794

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