Regulatory Affairs Specialist/ Junior RAS

Job title:

Regulatory Affairs Specialist/ Junior RAS

Company:

AstraZeneca

Job description

Regulatory Affairs Specialist/ Junior Regulatory Affairs SpecialistAbout a roleAs a part of AstraZeneca, You will be responsible to ensure licence to operate for our innovative products, perform regulatory activities for defined part of AstraZeneca portfolio and drive projects related with among others Regulatory Excellence and quality assurance. The position is an office-based role within Medical Department, that works closely and share knowledge with both global AstraZeneca teams and locally within cross-functional teams with individuals from Medical, Distribution/Supply chain, Market Access and Marketing departments.Main Duties & Responsibilities:

• Ensure Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA), line extensions and life cycle submissions/ maintenance.
• Coordinate translation proces and quality check for Product info for CP, MRP/DCP and nationally approved products
• Support local packs preparation & pack changes implementation to ensure labelling compliance
• Authoring and management of local part of Regulatory dossier and product knowledge according to AZ processes.
• Cooperate with cross functional teams to ensure regulatory contribution to product launches
• Monitor status of ongoing regulatory processes for assigned products and ensure outcome from Regulatory Authority is received on time
• Work closely and swiftly with local and global cross functional teams (Distribution/ Medical/ Commercial/Market Access, Marketing)

Key Performance Indicators

• Timely registration of the new drug products and lifecycle management activities
• Regulatory compliance and products available for Polish market from Regulatory perspective.
• High quality, no recalls of promotional materials due to unsecured Regulatory areas.
• Feedback from external (e.g. HA officers) and internal customers (e.g. global Regulatory Affairs, Business Units, Medical).
• Communicate key topics and relevant issues timely and proactively to RA Head and relevant line functions.

Essential requirements:

• regulatory experience in the pharmaceutical industry

• Master of Science in Pharmacy or other relevant biomedical/scientific background
• English written & spoken (very good)
• Working knowledge of the EU and local regulatory legislation guidelines relevant to role
• Strong personal integrity, customer and quality focus
• Ability to organize, prioritize and work effectively in a constantly evolving environment and with multiple priorities

Date Posted 10-wrz-2024Closing Date 01-paź-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Expected salary

Location

Warszawa, mazowieckie

Job date

Thu, 12 Sep 2024 07:31:45 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.