AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations, because we are committed to doing the right thing. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

The role:

• Ensures marketing authorizations for AstraZeneca products are in line with Regulatory Affairs requirements
• Prepares and collects local and global documents for submission to the National Medicine Agency and Medical Devices (NAMMDR) for authorisations/renewals/variations, various notifications, reports or NAMMDR correspondence.
• Provides technical review of data for regulatory submissions;
• Translates market product information (SPC/PIL/Labelling) and ensure artworks are updated in due time with current approved information; Ensures efficient and timely labelling process with successful launches and lifecycle management in the market.
• Responsible for regulatory compliance of artwork update projects;
• Works in close cooperation with European and global regulatory;
• Submits the initial and response documentation in due time to NAMMDR;
• Timely documents all submissions/approvals/post-approval commitments and responses in internal regulatory systems and timely communicates the SPC/PIL update to internal and external stakeholders;
• Maintains data integrity of product lifecycle management;
• Is up-to-date with all relevant changes in the regulatory environment and implements them into relevant local activities within Regulatory Affairs department;
• Provides relevant regulatory intelligence to other company departments (Medical, Marketing, Logistics, Market Access, etc);
• Supports Regulatory Manager to manage audits, regulatory agency inspections, product recalls;
• Contributes to the overall development of the department and positive attitude towards working and developing
• Active contribution to continuous improvements within Regulatory Affairs function;
• Active role and to ensure compliance with GRP (Good Regulatory Practice);
• Recall Administrator Deputy;
• Develops, maintains and implements standard operating procedures or local working instructions that regulatory compliance is maintained or enhanced.
• Collaborates with Regulatory Manager to implement processes changes to ensure a high regulatory compliance level and an “inspection readiness” mindset.
• Supports Regulatory Affairs Manager in identifying and documenting compliance risks/deviations and providing regulatory trainings to internal stakeholders.

The profile:

• Minimum of 2 years of lifecycle maintenance experience (safety and CMC variations, NAMMDR notifications/correspondence)
• Solid RA legislation knowledge
• Good project management skills
• Good understanding of national and European regulatory requirements;
• Labelling  and artworks update expertise
• Proactive approach; problem solving and negotiating skills
• Fluency in English
• Very well organized and able to deal with multiple and various tasks; attention to details

Date Posted

Closing Date

AstraZeneca 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.