Regulatory Affairs Manager - V&I
AstraZeneca AB / Kemiingenjörsjobb / Göteborg
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hela Sverige Do you have in depth knowledge within Regulatory Affairs and want to develop your skills within project management?
At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Vaccines and Immunology Therapies Areas.
We are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients' lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth.
The role
We are now seeking a new member to join our Regulatory Affairs Management team within the Vaccines and Immunology Therapies Areas, in the role as Regulatory Affairs Managers (RAM). This role will be based at AstraZeneca's dynamic R&D sites in either Gothenburg, Sweden or Cambridge, UK.
What you'll do
Working in the role as Regulatory Affairs Managers (RAM), you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions. With your knowledge, you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
Your main accountabilities/responsibilities:
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Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
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You will 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.
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Review of documents (e.g. response documents, study protocols, PSRs, etc.).
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Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. You'll use and share standard methodologies, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
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Lead and / or contribute to the planning, preparation (including authoring where relevant) 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.
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You'll develop, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated partners.
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Coordinate the input, maintenance and revision in the PLANIT project plans for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
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Identify regulatory risks and propose mitigations to Lead Regulatory Project Manager and cross functional teams.
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Support operational and compliance activities for assigned results, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
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Provide coaching, mentoring and knowledge sharing within the RAM skill group.
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Contribute to process improvement.
Do you have the essential qualifications for these roles?
To be successful in this role, we believe that you have a University degree in science or a related field. A minimum of 2 years of regulatory experience within the biopharmaceutical industry or at a health authority is needed and the role also require drug development knowledge.
We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.
If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.
So, what's next?
Are you already imagining yourself joining us? Good, because we can't wait to hear from you!
Welcome with your application no later than October 31st. We will review the applications continuously so please apply as soon as possible.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-10-13ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-11-10
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-150100".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
maria.elmberg1@astrazeneca.com Jobbnummer 7072928
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