Regulatory Project Manager for consulting assign. at AstraZeneca
Modis Sweden AB / Datajobb / Göteborg
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hela Sverige Modis Life Science is now looking for a Regulatory Project Manager for a consulting assignment at AstraZeneca in Gothenburg. The assignment will initially run for 12 months with starting date asap. Apply by sending your CV + cover letter no later than January 17th. Interviews are held continuously.
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 - and are made to feel valued, energized and rewarded for their ideas and creativity.
We are now looking to recruit a Regulatory Project Manager to the Late Cardiovascular, Renal and Metabolism (CVRM) Regulatory team in Gothenburg. Our team belongs to the Late CVRM Research & Development organization and is accountable for end to end regulatory project delivery, from phase 1 to marketed products, in line with business priorities, providing regulatory expertise, efficient project management and strong leadership. This is a temporary position, lasting for 12 months.
If you are interested in Regulatory Affairs and would like to work with broad outreach across Research & Development, health authorities and marketing companies world wide, this is an opportunity to join AstraZeneca and the Late CVRM Regulatory team. In Late CVRM Regulatory you will be part of a vibrant culture that values inclusion and diversity and gives people opportunity to grow.
About the role
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 regulatory procedures and submissions. 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 regulatory project teams, and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Accountabilities/Responsibilities:
* 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.
* 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) including:
- Submission delivery strategy of all dossiers and all application types per market and/or region.
- Review of documents (e.g. response documents, study protocols, PSRs etc.).
- Analysis of regulatory procedures and special designations used during development, authorizations and extensions of a medicinal product.
* Support operational and compliance activities for assigned regulatory tasks.
* Provide coaching, mentoring and knowledge sharing within the regulatory skill group.
* Contribute to process improvement.
Minimum Requirements - Education and Experience
* Relevant University Degree in Science or related discipline
* Regulatory experience, minimum 1 year, within the biopharmaceutical industry, or at a health authority, or other relevant experience
* General knowledge of drug development
* Strong project management skills
* Leadership skills, including experience leading multi-disciplinary project teams
Skills and capabilities
* Excellent written and verbal communication skills
* Cultural awareness
* Proficiency with common project management (e.g., MS Project) and document management tools
* Ability to work independently and as part of a team
* Influencing and stakeholder management skills
* Ability to analyze problems and recommend actions
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2020-01-10ErsättningFast lön
Så ansöker duSista dag att ansöka är 2020-01-17
Klicka på denna länk för att göra din ansökanFöretagModis Sweden AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Modis Sweden AB (org.nr 556694-0044),
http://www.modis.se/ Jobbnummer 5034250
Observera att sista ansökningsdag har passerat.