Regulatory Project Manager to AstraZeneca
Alten Sverige AB / Biomedicinjobb / Göteborg
Observera att sista ansökningsdag har passerat.
Visa alla biomedicinjobb i Göteborg,
Mölndal,
Partille,
Kungälv,
Lerum eller i
hela Sverige Visa alla jobb hos Alten Sverige AB i Göteborg,
Härryda,
Trollhättan,
Uddevalla,
Grästorp eller i
hela Sverige 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 - 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
What we offer you at ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams!
As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.
We believe in growing together!
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2020-01-10ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2020-01-17
Klicka på denna länk för att göra din ansökanFöretagAlten Sverige AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Alten Sverige AB (org.nr 556420-7453)
Jobbnummer 5034642
Observera att sista ansökningsdag har passerat.