Regulatory Project Managers

AstraZeneca / Apotekarjobb / Göteborg
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At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.

The Regulatory Project Management (RPM) group sits within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organisation and is accountable for end-to-end delivery of regulatory submissions in line with business priorities, by providing regulatory expertise, efficient project management and strong leadership.

We are now looking to recruit Regulatory Project Managers in Gothenburg within the RPM Cardiovascular, Renal and Metabolism (CVRM) & Clinical Trial Applications (CTA) team, and within the RPM Respiratory, Inflammation and Autoimmunity (RIA), Infection & Vaccines team.

The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory project teams, and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities:

* Monitor and interpret the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
* Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
* Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work.
* Lead and / or contribute to the planning, preparation and delivery of simple and with experience, increasingly more complex submissions throughout the product's life cycle from either a global and/or regional perspective.
* Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
* Coordinate the input, maintenance and revision in the project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
* Identify regulatory risks and propose mitigations.
* Support operational and compliance activities for assigned deliverables, including submission content plans, submission tracking,and document management utilizing the support and input of Global Regulatory Operations , Marketing Companies, CROs and/or alliance partners where relevant.
* Provide coaching, mentoring and knowledge sharing within the RPM skill group.
* Contribute to process improvement

Preferred Experience

* Relevant University Degree in Science or related discipline
* Minimum one year's experience of managing regulatory work
* General knowledge of drug development
* Strong project management skills
* Leadership skills, including experience leading multi-disciplinary project teams
* Excellent written and verbal communication skills
* Influencing and stakeholder management skills
* Continuous Improvement and knowledge sharing focused

More information

For more information about the position please contact

• Jan Hase (RPM CVRM & CTA) at + 46 709131934

• Karin Dotevall (RPM RIA, Inf & Vacc) at +46708467499

If you are interested, apply now!

Welcome with your application no later than April 21, 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

Publiceringsdatum
2018-04-09

Ersättning
Not Specified

Så ansöker du
Sista dag att ansöka är 2018-04-23
Ange följande referens när du ansöker: R-025856
Klicka på denna länk för att göra din ansökan

Kontakt
AstraZeneca asa.lothigius@astrazeneca.com

Företag
AstraZeneca

Adress
AstraZeneca
43183
43183 1480

Kontorsadress
Pepparedsleden 1

Jobbnummer
4069149

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Regulatory Project Managers

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