Regulatory Affairs Specialist

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

1. Provide an efficient and proactive Regulatory service to meet the business objectives.
2. Support proactively commercialization of products.
3. Ensure agility in daily interaction with authorities and competitive intelligence.
4. Cooperate closely with Central RA in regulatory Intelligence and policy area, submission planning and implementation of business excellence measures and business reporting.
5. Secure and timely complete new regulatory approvals in national and (if relevant) European approval processes.
6. Secure orderly and timely completion of all regulatory requirements to retain the registered product portfolio, its variation and, if decided, termination of approvals.
7. Ensure Local Labelling compliance and inspection readiness.
8. Secure the orderly and timely creation and maintenance of compliant regulatory documentation and labelling documents in line with agreed Ways of Working.

Responsibilities:

1. 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. Proactively review critical new legislation and guidance documents, share them with the central RA team, disseminate to relevant parties information of importance to the business.
2. Develop and build upon established relationships with 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.
3. Participate in the definition and implementation of 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 in problem-solving.
4. Plan and participate in the preparation of high-quality regulatory submissions to the authorities within agreed timeframes and according to agreed ways of working.
5. Closely monitor the progress of submissions and participate in the efficient preparation and submission of responses to deficiencies noted by regulatory authorities, supporting the earliest possible approval.
6. Inform relevant departments of deviations from regulatory schedules which may affect product supply.
7. Ensure that Marketing Authorisations are updated in line with new safety information in a timely manner and compliance monitoring and inspection readiness.
8. 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.
9. Archive all local labelling versions and communication in the appropriate database.
10. 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.
11. Highlight compliance issues with all products within the portfolio and make proposals for their resolution.
12. Perform administrative tasks to ensure effective operation of the department and company, including updating of the regulatory database, monitor and implement department KPIs.
13. Propose the requirement for, and contribute to, the writing and maintenance of relevant Standard Operating Procedures.
14. Schedule, prioritise the workload of team to ensure that targets are achieved and resources are used effectively.

Support to Market Access (whenever applicable):

1. Manage P&R requests to HA’s for retail and hospital products.
2. Manage price updates (such as increases, decreases or price revisions by HA’s).
3. Support Annual Price revisions.
4. Monitor legislation related to prices and ensure it fulfills national legislation.

Support to Medical:

1. Support of upcoming launches.
2. Responsible for Medical compliance – elaboration, revision and approval of educational materials, promotional and non-promotional materials and events, adherence to Industry Codes of Practice.
3. Support to medical information function.
4. To be in contact with external Key opinion leaders (when applicable).

Support to the Ethical Compliance (transparency reporting):

Support to Pharmacovigilance (whenever applicable):

1. Maintain routing of relevant web-links locally presented as a web of Side effects alerts.
2. Literature screening.
3. Support Periodic Reports (planning, local submissions).
4. Ensure local support to Market Research.

Skills, Experience & Knowledge Requirement:

1. Pharmacy Degree.
2. Good command of Microsoft-Windows tools.
3. National/European legislation and internal regulation acquaintance.