Regulatory Affairs Director
AstraZeneca Södertälje / Läkarjobb / Mölndal
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hela Sverige 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. In this your you should possess strategic leadership skills, have an understanding of regional and/or global regulatory science and overall drug/biologic development processes and strategies. You also should have 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. As necessary, the RAD may also take on the Global Regulatory Lead (GRL) role for a product/group of products.
Minimum experience
• 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.).
• >5 years experience or equivalent 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.
More information
Your application is welcome no later than February 11, 2015.
Publiceringsdatum2015-01-30Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-02-10
Ange följande referens när du ansöker: MOL000001JC
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Västra Mälarhamnen 9
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2149429
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