Regulatory Project Manager at AstraZeneca i Gothenburg

Publicerad: 2017-07-07
Ort:
Gothenburg, Västra Götalands län
Kategori:
Life Science
Specialisering:
Läkemedel, bioteknik & medicinteknik
Omfattning:
Visstid
Referensnummer:
201068947
Sista ansökningsdag:
2017-08-17
Kontakt:
Birgitta Nyström
On behalf of our client, we are now searching for a regulatory specialist to work as a consultant in an innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases.

The arena
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 regulatory project delivery, providing regulatory expertise, efficient project management and strong leadership in line with business priorities.

We now have the opportunity for two-three individuals to join the team at AstraZeneca in the role as Regulatory Project Managers (RPMs) within the RPM RIA, Inf & Vacc team, and the RPM CVMD & NS team in Gothenburg. The roles are on a temporary basis for one year.

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 GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), 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 deliverables.

· 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 OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.

· Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.

· Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, Trial Master File (TMF), 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

Business: Dfind Science & Engineering

City: Gothenburg

Deadline for applications: 2017-08-17 but since selection is done continuously please apply as soon as possible.

More information: If you have any questions please contact us; Birgitta Nyström, birgitta.nystrom@dfind.se

Organization/Business description:
Dfind Science & Engineering is part of Randstad, one of the Nordic region’s largest specialists within staffing, recruitment and outplacement. Dfind Science & Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists! All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.