Associate Regulatory Affair Director - R&I (RAD group)
AstraZeneca AB / Kemiingenjörsjobb / Göteborg
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hela Sverige Do you have in depth knowledge within Regulatory Affairs and want to develop your strategic skills? 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 provide strategic input to the development, commercialization and life cycle management of our products and serve as a regional regulatory leader. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Respiratory and Immunology and Vaccines and Immunology Therapies Areas.
At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines and patients.
The Global Regulatory Affairs Therapeutic area team is a strategic function within the Respiratory & Immunology Development organisation. The Regulatory Affairs team leads the development and execution of regulatory strategies for global programmes across the entire lifecycle by proactively leveraging and applying the broad regulatory and scientific expertise, leadership skill and business acumen to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients.
The role
We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the role as Associate Regulatory Affair Director (ARAD). You will be part of the RAD group. This role can be based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden) or Macclesfield (United Kingdom).
What you'll do
Working in the role as Associate Regulatory Affairs Directors (ARAD), 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 provide strategic regulatory input to the development, commercialisation and life cycle management of the assigned products. The ARAD serves as the regional regulatory leader and provide ad hoc project input to support regional RAD or GRLs for specific project tasks. This is a truly inspiring role where you will play a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. The ARAD could under take leadership of cross- functional Teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. As a regional regulatory lead or contributor, the ARAD is a member of the Global Regulatory Strategy Team (GRST) accountable for providing the region-specific Regulatory strategy and advice. You will serve as the face of the company with Health Authorities.
Your main accountabilities/responsibilities:
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Accountable for delivering on various regional regulatory strategic areas such as orphan designation, scientific advice, paediatrics and submission content and objectives. This includes health authority engagement strategy and considerations of expedited regulatory programs.
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Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
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Member of a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
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May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs), supported by GRL, providing strategic Regulatory advice and be accountable for all Regulatory activities
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Contribute to the preparation of the regulatory strategy document and target product labeling.
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Develop strategic leadership skills contributing to effective product development.
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Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands.
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Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
Do you have the essential qualifications for these roles?
To be successful in these roles, we believe that you have an advanced degree in science or a related field together with a deep understanding of and proven experience from Regulatory Affairs within at least one therapeutic area in early and late development. You have prior involvement in Health Authority interactions, including end of phase 2 health authority interactions and scientific advice, regulatory defense is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be an advantage.
You possess excellent leadership and project management skills as well as emerging competency in strategic thinking, strategic influencing, innovation, initiative, and strong oral and written communication skills.
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 18 June. We will review the applications continuously so please apply as soon as possible.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-06-19
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-168119".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
maria.elmberg1@astrazeneca.com Jobbnummer 7850135
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