Regulatory Affairs Specialist

Regulatory Affairs Specialist

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development.

What you’ll do:

Regulatory Affairs:

• Responsible for Linguistic Review process for centralized products, complying with relevant AstraZeneca procedures and external regulations within specific deadlines.
• Handle local Regulatory submissions in National/MRP/DCP procedures, including document management and archiving.
• Ensure local documentation contributions to Regulatory Management System for regulatory submissions align with relevant AstraZeneca procedures and external requirements, using AstraZeneca Regulatory systems.
• Communicate Bulgarian Drug Agency outcomes, commitments, and registration status parameters to the Regulatory Submission Management Group
• Ensure timely update of regulatory submission tracking system.
• Keeping Regulatory Management System and local SharePoint site updated with the latest approved Market Product Information documents.

Labelling:

• Responsibility and traning in the process related to the creation of the artwork for Bulgarian language market specific pack in AstraZeneca Global Labelling system in accordance with local legislation & relevant AZ SOPs
• MC Regulatory Approver and Reviewer in AstraZeneca Global Labelling system as per GLBP SOP and acting as MC Regulatory Initiator when needed;

Regulatory support for Non-Interventional Studies

• Provides regulatory intelligence input and regulatory support for non-interventional studies Regulatory submission and approval

Professional qualifications and experience:

Essential:

• University Science degree or relevant experience statutory qualifications required within Bulgaria
• Experience in Regulatory Affairs of minimum 4-5 years
• Good verbal and written communication skills.
• Strong computer skills.
• Excellent English
• Knowledge of regulatory systems and relevant procedures.
• EU pharmacovigilance knowledge.
• Knowledge of local and EU Authorization procedures and post-market requirements.

Desirable:

• Knowledge of the drug development process, product life-cycle, and contents/formatting of national regulatory submissions.

At AstraZeneca, we play a critical role in making our pipeline accessible to patients. We are a research-driven enterprise, always working on something new. Our knowledge of patients, fused with our forward-looking mindset and innovations, helps us to spot opportunities and approach access sustainably. We are a team of knowledgeable experts who are comfortable with complexity. We develop and execute pricing and market access strategy to ensure patients have access to our medicines. Here you get high levels of autonomy. We thrive on the accountability and trust. If the idea of leading a mindset shift sounds appealing, then this is the place for you.

Ready to make a difference? Apply today and join us!

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 authorisation and employment eligibility verification requirements.