Regulatory Affairs and Medical Systems Specialist

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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WHAT - Summary & Purpose of the Position

To

1/ Manage regulatory activities for products and medical devices from the early stage through all lifecycle.

The Regulatory Affairs function is also responsible for end to end labelling process including artwork management and providing expertise of local regulations and requirements to global functions and local employees.

2/ Design and lead optimal compliant and cost-efficiency pharmacovigilance

activities including oversight of pharmacovigilance third parties.

This role is designed to be the point of contact for Global Patient Safety as well as any Pharmacovigilance vendor performing activities and commercial partner operating in Poland. As such this role will need to maintain a robust oversight of the pharmacovigilance activities performed by those partners.

This role must also ensure the Quality Management System for Pharmacovigilance in the Polish Affiliate is designed in compliance with European and national regulations as well as Ipsen policies and is inspection-ready at all times.

3/ Navigate Medical Information.

This is the role of country contact for MISTRAL provider- updates control etc. Also all submitted cases of Med Info must be managed properly according to internal and external rules.

4/ Update data privacy procedures incorporate locally all required tools.

This is the role for country contact to regional/ cluster Data Privacy Champion. All the tasks must be completed in timely manner and the systems updated.

Main Responsibilities & Technical Competencies

A/ Regulatory Function:

• Prepares documentations required for registration/renewals and variations formedicinal products
• Submits applications for registration renewals and variations
• Supervises the process of registration renewals and variations and provides optimalsubmission strategy and specific guidelines in collaboration with the headquartersand management local affiliate
• Receives market authorizations other registration documents/certificates
• Informs Global Regulatory Affairs and relevant local employees about submissionsapprovals and ongoing process of registration renewals and variations
• Updates of RA related databases and ensure their compliance
• Managing submission of variation related to product information texts
• Provide translation of common product information texts approved in DCP/MRP/CP
• and provide peer review checks of product information for submission
• Updating artworks following variations approval
• Coordinates packaging projects in global tool (initiator reviewer approver role)
• Controls and approves promotional material and non promotional materials ensureits compliance with local regulations and approved product information texts
• Develops and maintains good relations with the respective regulatory authorities andorganizations
• Provide response to regulatory authorities questions and requests for additionalinformation as the primary point of contact for any communication with the localauthority
• Close collaboration with Global Regulatory Affairs
• Maintain a high level of compliance to existing local and global standards in their
• activities (especially related to safety variation implementation PSURs submission
• RMP and Safety commitment management) - KPI
• - Active membership in industry organization
• - Regulatory support in cross functional team collaboration
• - PV reporting according to local rules and internal requirements
• - Provide expert knowledge of local regulations including Polish Pharmaceutical Law
• and Polish Health Authorities specific requirements to Global Regulatory Affairs;
• Provide information on regulations and products information based on approveddossier.

• B/Pharmacovigilance

• Pharmacovigilance Service provider management
• Exhibit excellence leadership skills to guide pharmacovigilance service providersstaff and seamless cooperation between external and internal stakeholders as wellas country-level and global functions
• Liaise with all functions including commercial partners service providers thirdparties and critical Ipsen functions such as medical affairs regulatory affairsmedical information etc. to secure communication flows and processes impactingpharmacovigilance requirements
• Ensure awareness and maintain oversight of any program and/or digital mediatriggering the collection of safety data to ensure appropriate pharmacovigilancerequirements are set up as per Ipsen policies and national laws
• Ensure awareness and maintain oversight of any Polish agreement requiring pharmacovigilance language and ensure inclusion of appropriate safety agreement.
• Pharmacovigilance Quality Management System
• Ensure the setup the maintenance of all PV activities are delivered in line with localguidelines legislation as well as local and global Ipsen Policies and SOPs
• Support and attend affiliate/GPS meetings to ensure awareness of any changes inglobal and/or regional requirements of the PV system
• Escalate safety compliance and operational issues to GPS in addition to thelocal Leadership.
• Ensure deviations from pharmacovigilance processes are documented and track and ensuring that appropriate Corrective action and Preventive Action (CAPA) aredeveloped and implemented to address identified issues
• Ensure the set up and maintenance of a Pharmacovigilance Business Continuity
• Plan for the operations conducted in Poland and ensure its testing as per Ipsenpolicies
• Coordinate prepare and participate in regulatory authority pharmacovigilanceinspections and internal audits in Poland and support the development of answers to findings.
• Ensure compliant safety documentation archiving according to national laws andprivacy data laws

• C/ Medical Information.

• Medical Information Service (MISTRAL) provider management
• Exhibit excellence leadership skills to guide service provider staff and seamlesscooperation between external and internal stakeholders as well as country-level and global functions (updates trainings reconciliation etc)
• Liaise with all functions including third parties and critical Ipsen functions such asmedical affairs regulatory affairs whenever necessary to secure communicationflows and processes impacting medical information requirements
• Ensure awareness and maintain oversight of any Polish agreement requiring medicalinformation and ensure inclusion of appropriate safety agreement.

D/ Data Privacy Champion.

• Oversee and support Privacy Assessments in the One Trust Privacy system for theirbusiness area including:
• Coordinating the effort to ensure that there are OneTrust Privacy Assessments for allrelevant activities.
• Providing general support to the business area on when and how to complet Privacy Assessments.
• Reminding colleagues of requirements for assessments.
• Reviewing Basic Privacy Impact Assessments for risk and quality issues.
• Coordinating the Q1 review of assessments - this involves working with businessareas across the function or country to ensure coverage.
• Be the point of contact with the global privacy team for any matters to do with privacyin the business area as needed. For example:
• Supporting audits by providing basic information referring to the GPO where necessary.
• Supporting and helping to coordinate actions related to data breaches.
• Support monitoring exercises.
• Help raise awareness of privacy matters and provide support in the business areasuch as:
• Answering basic questions about data privacy matters for their team.
• Sharing newsletters with local or functional teams.
• Communicate with local teams leadership groups or functional areas about
• upcoming matters such as Q1 reviews changes in processes new guidance or upcoming training.
• Support development of basic compliance matters such as:
• Ensuring that Privacy Notices are present and correct in liaison with the relevantlegal representative.
• Developing appropriate SOPs INS for guidance for their areas.
• Supporting areas of focus such as deployment of new processes.
• Be involved in the Privacy Champion network including:
• Taking part in Privacy Champion training
• Attending and contributing to monthly meetings
• Keep up to date with Global Privacy Policies and Guidance
• Single Point of Contact for Data Privacy above country function.
• Monitoring and update systems and databases regarding data privacy protectionaccording to internal and external rules.
• Systematic review and monitoring of business practices

E/ General:

• Collaboration with other Departments
• Proactively advocate for quality processes across functions;
• Proactively identify areas for process improvement and mediate cooperation cross functionallyto effect and implement the Quality System;
• Contribute towards stakeholder value by providing quality leadership and operationalinput towards affiliate strategic and tactical activities;
• Strengthen the risk management culture and support the update of the Ipsen PolandRisk management systems.

Education / Certifications:

• Ideal: Degree or equivalent work experience in scientific or health related field
• Minimum: Degree in Scientific discipline (Pharmacy Chemistry or Biological
• Sciences)

Experience:

• At least 1 year experience in a similar position in a multinational pharmaceutical
• company
• Strong quality orientation
• Working in a matrix organization and interfacing with lead/management team.
• Ability to work with high workload and time pressure
• Strong organizational abilities
• Ability to balance between detail orientation and overview with a good business
• acumen
• Broad pharmaceutical business and Local regulations knowledge
• Proven experience and leadership within Quality operations of multi-national
• biopharmaceutical settings;
• Extensive understanding of GxP Systems and Pharmaceutical responsibilities
• Languages:
• Fluent English and Polish language

Key Technical Competencies Required

Strong communication skills

Solid presentation skills

Team-player

Acts as a Business Partner

Ethical behavior

Sense of urgency

Analytical problem-solving and high-level organizational and time management skills;

In-depth knowledge of relevant bio-pharmaceutical legislation and QMS requirements

including GxP standards Pharmacovigilance regulations.

Good understanding of operational platforms and validated databases to execute GxP

quality compliance

Ability to thrive in cross-functional environment (matrix organization)

Ability to influence negotiate and project manage

Key Internal stakeholders: All GXP Areas and Functional Areas of the Organization

Key External contacts: Vendors Governmental / Regulatory Authorities

Number of direct reports: N/A oversight of external vendors required

Travel: Required for self-inspection when applicable; F2F Quality Meeting

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