Regulatory Affairs Specialist

Mission

The Regulatory Affairs Specialist at local/country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include:

Provide an efficient and proactive Regulatory service to meet the business objectives

Support proactively commercialisation of products

Ensure agility in daily interaction with authorities and competitive intelligence

Cooperate closely with Central RA in regulatory Intelligence and policy area, submission planning and implementation of business excellence measures and business reporting

Secure and timely complete new regulatory approvals in national and ( if relevant ) European approval processes

Secure orderly and timely completion of all regulatory requirements to retain the registered product portfolio, its variation and, if decided, termination of approvals.

Ensure Local Labelling compliance and inspection readiness

Secure the orderly and timely creation and maintenance of compliant regulatory documentation and labelling documents in line with agreed Ways of Working

Support to other areas within Scientific Affairs:

Market Access

Medical

Pharmacovigilance (whenever aplicable)

Responsibilities

Develop and maintain a comprehensive understanding and interpretation of EU and country regulatory requirements, to enable regulatory submissions to be compiled in line with current requirements. Pro-actively review critical new legislation and guidance documents, share them with central RA team, disseminate to relevant parties information of importance to the business.

Develop and build upon established relationships with the local Regulatory Authorities and other relevant organisations and personnel including local Pharmaceutical and Regulatory Associations, in order to facilitate activities required to meet the needs of the business

Participate on the definition and implement regulatory strategies and be proactively involved in the decision-making process in order to achieve registrations in a timely manner and in line with company goals. Consider potential obstacles to approval of regulatory submissions and actively participate on problem solving

Plan and participate in the preparation of high quality regulatory submissions to the authorities within agreed timeframes and according to agreed ways of working

Closely monitor the progress of submissions and participate on the efficient preparation and submission of responses to deficiencies noted by regulatory authorities, supporting the earliest possible approval.

Inform relevant departments of deviations from regulatory schedules which may affect product supply.

Ensure that Marketing Authorisations are updated in line with new safety information in a timely manner and compliance monitoring and inspection readiness. Ensure local originator and other local requirement monitoring. Timely evaluate impact of all Local, EU and Global outcomes on local labelling and manage change control for national procedure. Cooperate with Central team on evaluation, timely implementation and change control for harmonised and centralized procedures in order to ensure compliance with given deadline corporate requirements. Any deviation from submission due date must be communicated and sufficiently explained in regulatory database.

Prepare and review local / local mutation of Summary of Product Characteristics, Package leaflets and text of packaging to ensure compliance with current legislation and registered particulars and take action to secure regulatory approval where necessary. Ensure quality check and Local specific part of labelling variation dossier. Prepare English back/translation according requirements.

Archive of all local labelling version and communication in appropriate database. Ensure communication of last approved labelling and ongoing labelling variation within affiliate [supply chain, medical, pharmacovigilance, quality, marketing] and toward Central RA team.

Communicate with supply chain and quality to ensure regulatory strategy is implemented within agreed time-frames to achieve an uninterrupted supply of compliant product to the market. Cooperate with supply chain on new Vista folder creation within timely manner, determination of compliance date and market regulatory validation.

Highlight compliance issues with all products within the portfolio and make proposals for their resolution. Actively solve issues concerning product compliance

Perform administrative tasks to ensure effective operation of the department and company, including updating of the regulatory database, monitor and implement department KPIs

Propose the requirement for, and contribute to, the writing and maintenance of relevant Standard Operating Procedures. Formulate proposals for, and drive the development of new initiatives within the department and company

Schedule, prioritise the workload of team to ensure that targets are achieved and resources are used effectively

Support to Market Access (whenever applicable):

Manage P&R requests to HA's for retail and hospital products;;

Manage price updates (such as increases, decreases or price revisions by HA's)

Support Annual Price revisions;

Monitor legislation related to prices and ensure it fulfills national legislation;

Support to Medical:

Support of upcoming launches

Responsible for Medical compliance – elaboration, revision and approval of educational materials, promotional and non-promotional materials and events, adherence to Industry Codes of Practice

Support to medical information function;

To be in contact with external Key opinion leaders (when applicable)

Support to the Ethical Compliance (transparency reporting)

Support to Pharmacovigilance (whenever applicable):

Maintain routing of relevant web-links locally presented as a web of Side effects alerts

Literature screening;

Support Periodic Reports (planning, local submissions)

Ensure local support to Market Research

Skills, Experience & Knowledge Requirement

Pharmacy Degree

English fluency

Good command with Microsoft-Windows tools

National/European legislation and internal regulation acquaintance

+10 years of similar experience

Sense of ethics and responsibility

Sense of organization and planning

Transversal cooperation

Effective communication

Proactivity

Focus on problem solving

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