Regulatory Affairs Specialist undertakes regulatory activities for defined products and projects as well as provides a comprehensive support to Regulatory Head.

Acts in full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards.

Job Responsibilities

Related to assigned products/portfolio and RA team

• Ensures high-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA), line extensions and life cycle submissions/ maintenance.
• Provides translations for centrally, MRP/DCP and nationally approved products ensuring timely and quality results, information flow between RA and other departments, cooperation between RA, QA and Supply Chain.
• Manages local packs preparation, pack changes implementation and artwork clearance to ensure labelling compliance.
• Works cross-functionally with local colleagues to advise and agree on regulatory strategy, clinical development plans and data requirements.
• Ensures submissions are made in accordance with accepted regulatory standards within appropriate and agreed timeframes.
• Creates and maintains the country specific part of dossier including official local product information.
• Ensures proper archiving of all documents submitted to the Health Authority and related correspondence according to AZ requirements.
• Monitors and influences assessment process to expedite and optimize the outcome of the submissions/ approvals. Drive negotiations with Health Authority to ensure best possible product labelling and delivery of their commitments and deadlines.
• Works closely with local brand teams to ensure launch readiness plans are in place in order to successfully launch products.
• Proactively monitors status of post-approval commitments made to Health Authority and ensures their timely completion.
• Works closely and swiftly with cross functional teams in case of critical issues, e.g. related to batch recall or other product related issues.
• Ensures proactivity and collaboration for successful engagement with internal & external stakeholders.
• Performs other tasks in accordance with general job description as required.

Regulatory Intelligence & Policy

• Provides relevant regulatory competitor intelligence (e.g. generic submissions) and communicate to local management and global RA as appropriate.
• Responsible for establishing good professional working relationships with external stakeholders, including Health Authority.
• Represents AZ at local Pharma Trade Association bodies for regulatory relevant agenda, according to RA department needs.

Processes & Compliance

• Ensures accurate and timely data update of local and global regulatory compliance databases for assigned products.
• Upon request contributes to development and maintenance of relevant local SOPs.

Key Performance Indicators 

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

Typical Accountabilities (per AZ framework and regulatory expectations):

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Education, Qualifications, Skills and Experience

Essential Qualifications

• Master of Science in Pharmacy or other relevant biomedical/scientific background
• English written & spoken (very good)
• Previous industry working experience, preferably in Regulatory Affairs/Patient Safety/Quality Assurance dept.
• Working knowledge of the EU and local regulatory legislation guidelines relevant to role
• Strong personal integrity, customer and quality focus
• Must be able to organize, prioritize and work effectively in a constantly evolving environment and with multiple priorities

Desirable Qualifications

• Experience in project management

Key Relationships to reach solutions

Internal (to AZ or team)

• Medical Team
• Marketing Department
• Market Access Department
• Supply Chain and Quality Assurance
• Global Regulatory functions

External (to AZ)

• Health and Regulatory Authorities (Ministerstwo Zdrowia, Urząd Rejestracji Produktów Leczniczych, Główny Inspektorat Farmaceutyczny, Narodowy Instytut Leków)
• local Pharma Trade Associations

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.  AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

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.