Executive Regulatory Affairs Director
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige Regulatory Affairs is part of Global Medicines Development (GMD) which drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
We provide strategic regulatory expertise and oversight to support the Research, Development and Commercialisation of products for the disease area or stages of development within the TA portfolio across both small molecules and biologics and ensure adequate regulatory resource and skills for projects in line with designated disease area portfolio.
The Respiratory, Inflammatory and Autoimmune (RIA) team is currently seeking an experienced Executive Regulatory Affairs Director / Group Manager to join a group of capable and knowledgeable colleagues.
Location: Gothenburg, Sweden
As the Executive Regulatory Affairs Director / Group Manager you will possess strategic leadership skills, have a deep understanding of global regulatory science, the overall drug development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders. The ability to function in multiple capacities to deliver the overarching global regulatory strategy is a requirement for this role.
This role ensures that the disease area strategies in the TA are designed to deliver positive regulatory outcomes which meet the needs identified by the business, markets and patients.
Main Duties and Responsibilities
Disease Area Regulatory Strategies
You will partner with the Regulatory Affairs Directors (RADs) to align on the regulatory strategy for a product(s) and ensure it is consistent with the disease area or TA portfolio strategy.
You will provide critical review and input on disease area or portfolio regulatory strategies, risk planning and mitigations.
You will ensure disease area global regulatory strategy take into account key regional considerations.
You will effectively represent the regulatory function in senior level interactions at internal governance technical review committees e.g. Development Review Committee (DRC), Innovative Medicines & Early Development Leadership Teams for AZ or MedImmune Science Units, Global Medical Affairs (GMA) Review Committees.
You will work in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment, in a given disease area, against aspirations within the TA (or part of the TA), and advises senior management on project risks/mitigation activities accordingly.
You will define and drive disease area regulatory policies and priorities within the TA (or part of the TA) with e.g. regional policy and intelligence groups through a strategic influencing plan with internal and external stakeholders.
You will effectively represent the Global Regulatory Affairs (GRA) function at key global health authority meetings and with external stakeholders.
Essential Requirements
* Bachelor's degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
* Very considerable drug development experience
* Experience in global regulatory strategy and submissions that have progressed through to registration
* Must have significant experience in leading major health Authority interactions
* Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
* Broad experience of the respiratory, inflammation and autoimmune therapeutic area, with specific disease area regulatory sciences expertise
* Experience in managing people in a matrixed organizational structure.
* Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities.
* Effective judgement and decision-making in complex business critical situations
* Must demonstrate competencies of strategic influencing (of key stakeholders/leaders), innovation, initiative, and leadership.
* Excellent collaboration, team working, oral and written communication skills.
* Willingness to undertake domestic and international travel.
Desirable
* Advanced degree in a scientific discipline (e.g. MSc, PhD, PharmD, MD)
If you are interested, apply now!
Welcome with your application no later than 30th April 2018.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-03-07ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-03-21
Ange följande referens när du ansöker: R-023962
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
asa.lothigius@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4007724
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