Regulatory Project Manager at AstraZeneca Gothenburg

Poolia Göteborg AB / Apotekarjobb / Göteborg
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We are now looking for a talented Regulatory Project Manager at AstraZeneca Gothenburg. The 12-months consulting assignment will start 2019-01-07. Warmly welcome to Poolia Life Science and AstraZeneca. If you are interested, apply today!

About the consulting assignment
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 now have a temporary position as a Regulatory Project Manager within the RPM CVRM, NS & CTA team in Gothenburg. The assignment is for 12 month starting in January 2019. 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 strategies, 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.
• 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.

About you
Preferred Experience:
• Relevant University Degree in Science or related discipline
• 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

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives to feel valued, energized and rewarded for their ideas and creativity.
Warmly welcome to Poolia Life Science Göteborg and AstraZeneca!

Varaktighet, arbetstid
Heltid Tillsvidare

Publiceringsdatum
2018-10-24

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Sista dag att ansöka är 2018-10-31
Ange följande referens när du ansöker: 51707
Klicka på denna länk för att göra din ansökan

Företag
Poolia Göteborg AB

Adress
Poolia Göteborg AB
Kungsgatan 42
41115 Göteborg

Kontorsadress
Kungsgatan 42

Jobbnummer
4420646

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