id: MjUzNjk5IDEyMQ

reference: 253699

documentId: 7987897

connectionPointId: 121

lastModificationDate: 1540277520643

Jobbtitel: Regulatory Project Manager at AstraZeneca

Arbetsbeskrivning:
Regulatory Project Manager We are now looking for a Regulatory Project Manager for a 12 months consultant assignment at AstraZeneca in Gothenburg. 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. AstraZeneca has now 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 Business: Dfind Science & Engineering City: Gothenburg Deadline for applications: 2018-11-01. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience! For more information contact: Malin Wåhlberg malin.wahlberg (at) dfind.se or Birgitta Nyström birgitta.nystrom (at) dfind.se Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there. Organization/Business abstractJV_description: Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills. Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0:
Link to the vacancy on the Swedish job board

requiredEducationLevelCode: 0

requiredYearsOfExperience: 0

positionTypeCode: temporary

contractTypeCodes_0: fulltime

Arbetsgivare Namn: Dfind Science & Engineering AB

source: PES-SWEDEN