Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Warsaw

Regulatory Affairs Manager manages regulatory activities for defined products.

RA Manager manages self-reliant projects and perform leadership role in the projects assigned by Regulatory Head.

RA Manager supports RA Head in:

• designing, communicating and implementing innovative regulatory strategies to provide the most efficient path to product approval and maintenance, minimizing regulatory issues and unnecessary delays,
• providing effective regulatory support to Poland and global RA Organisations for assigned products development and maintenance, including input into regulatory strategy,
• taking over assigned responsibilities and acting as a back-up in the assigned areas.

As GRP Quality Lead has the responsibility for ensuring the effective operational implementation of the QMS appropriate to the GRP area.

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.
• Coordinates RA activities with other Teams – Market Access, Distribution by leading regular meetings and communication.
• Leads assigned regulatory projects to ensure all stakeholders are identified and involved in the project, appropriate communication is in place and timelines agreed.
• Manages translation process 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, 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.
• Ensures the country specific part of dossier including official local product information is created and maintained according to AZ standards and HA requirements.
• 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.
• Acts as a mentor/coach for newcomers and less experienced members of RA team to assure completion of organizational goals, in a diverse and inclusive environment.
• 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.

GRP Quality Lead role: 

• Ensures local GRP QMS is up to date
• Provides and coordinates training and coaching in GRP area for RA team
• Identifies and agrees areas of compliance risk and follow-up of any issues 
• Ensures GxP self-assessments in GRP area  
• Monitors KPIs in GRP area and proposing remedial and improvement actions  
• Establishes improvement priorities  and manage change controls
• Monitors internal/external factors such as emerging regulation or shifts in regulatory enforcement  
• Identifies trends and communicating identified risks  
• Establishes and maintains business continuity plans in GRP area 

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, MA, Distribution).
• Communicate key topics and relevant issues timely and proactively to RA head and relevant line functions.

Education, Qualifications, Skills and Experience:

Essential:

• Life Sciences Degree or appropriate professional qualifications
• Very good english written & spoken
• Extensive broad regulatory experience in the pharmaceutical industry dealing with a wide variety of registration projects and issues
• 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
• 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:

• Leadership skills
• Experience in project management

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.