Regulatory Project Manager at AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma is looking for a competent and experienced Regulatory Project Manager for a consultancy assignment at AstraZeneca in Gothenburg.
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.
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.
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 ALTEN:
FOR OVER 20 YEARS, ALTEN HAS DEVELOPED ITS BUSINESS BY KEEPING TO THE CORE VALUES ??THAT HAVE BUILT UP THE COMPANY'S SUCCESS. EVERY YEAR, HUNDREDS OF ALTEN CONSULTANTS HAVE BEEN GIVEN THE OPPORTUNITY TO EMBARK ON CHALLENGING TECHNICAL PROJECTS FOR OUR CUSTOMERS. ALTEN HAS A TRADITION OF DEVELOPING PRODUCTS IN MANY AREAS, AND HISTORY IN SWEDEN IS BASED PRIMARILY ON SKILLS IN MECHANICS, SOFTWARE AND ELECTRONICS. THANKS TO A SUCCESSFUL CONCEPT IN WHICH WE UTILIZE THE EXPERTISE OF EXPERIENCED CONSULTANTS AND DEVELOP YOUNG ABILITIES TOWARDS A SUCCESSFUL CAREER, WE HAVE GAINED GROUND IN MANY INDUSTRIES. OUR PHARMA INITIATIVE IS BASED ON THE SAME SUCCESSFUL CONCEPT WITH THE SAME STRONG STRUCTURE, BUT IN A NEW EXCITING INDUSTRY AND A NEW FIELD OF EXPERTISE THAT INCLUDES KNOWLEDGE IN CHEMISTRY, BIOTECHNOLOGY AND BIOMEDICINE.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-10-23ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-31
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4417266
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