Regulatory Affairs: 

• responsible for the regulatory knowledge and expertise in the territory
• supports the Company’s regulatory activities by providing expert guidance and supporting cross functional decisions on aspects of regulatory affairs within the territory and the region
• acts as the primary Regulatory Affairs point of contact between the company and national Agency for Medicines and Medical Devices of Romania, coordinating and managing all relevant local regulatory affairs activities
• acts as the key liaison with Regulatory Authorities in cluster countries, ensuring effective communication, alignment, and execution of regulatory affairs activities
• supports the RA Ass. Director in all RA activities and implements the Company’s regulatory strategy

Pharmacovigilance:

• responsible for the pharmacovigilance knowledge and expertise in the territory
• supports the local pharmacovigilance activity regarding Company’s products
• serves as a local pharmacovigilance contact to the Partners and/or local Regulatory Authorities
• ensures compliance with the applicable Pharmacovigilance regulations and Medison corporate policies in the EPM region or in cluster countries under responsibility as appropriate.

Areas of Responsibility

Regulatory Affairs:

• Overall responsibility for regulatory activities in cooperation with corporate functions for products where Medison is MAH and for partners’ products according to the business agreement.
• Development and implementation of regulatory strategic plans.
• Take part in identification of new RA vendors (when applicable), qualification of new and existing RA vendors. Cooperation and oversight of RA vendors in the countries under the scope of responsibility.
• Provide regulatory information/collaborate for development of the market access to align with products value proposition.
• Preparation of submission documents for approving drug codes and blue box (where applicable).
• When necessary, assist in the training of staff in regulatory policies or procedures.
• Establish regulatory priorities and budgets.
•  Maintain current knowledge of relevant regulations/policies/guidelines/initiatives.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Demonstrate effective communication, collaboration and leadership with all necessary stakeholders and partners to maximize ability to execute objectives in timely manner and with efficiency.
• Represent the organization with internal & external stakeholders.
• Ensure Health Professional communications, public communications, promotional materials and press releases are aligned to corporate regulatory standards and policies, and compliant with regulatory requirements.
• Ensure compliance with Medison SOPs and partners’ procedures according to business agreements, when applicable.
• Create/update RA SOPs.
• Take part in regulatory audits.

Pharmacovigilance:

• Establishing and maintaining local pharmacovigilance system and procedures covering all activities required by regulations and safety agreements with partners.
• Collecting, reviewing, performing quality check and forwarding of Adverse Events and other safety information obtained through various sources to MAHs; tracking and archiving AEs; performing reconciliation activities and documentation. Managing the Adverse Events through Veeva Safety Vault.
• Perform follow-up activities as applicable, track and document.
• Monitor cluster safety mailboxes under responsibility or other EPM cluster safety mailboxes as back up on a daily basis to meet safety reporting obligations.
• Perform local translations of ICRS, PSUR, RA correspondence, regulatory intelligence as required, and oversight the activity where translation service is outsourced in the cluster countries under responsibility.
• Management of AEs related to Quality Complaints and Medical Information Queries.
• Submission of safety data to the local Regulatory Authority according to local regulations.
• Oversight of data generating activities within the cluster countries under responsibility to ensure any solicitation of information includes an appropriate review and reporting process for reporting potential AEs (e.g., Patient support programs, market research surveys, internet sites etc.) as applicable.
• Have safety oversight of clinical projects and pre-authorization access conducted in the cluster countries under responsibility.
• Support of compilation of aggregate reports by providing requested data to partner, as applicable, plan and ensure timely submission of Aggregate Reports according to local Regulations (if applicable).
• Perform/oversight local literature search.
• Support and implement Business Continuity Plans (e.g., inspection readiness, AE reporting coverage), ensure an effective system is in place for 24-h coverage and ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained.
• Ensure and implement an appropriate PV and Risk Management in place in order to assure appropriate oversight for the implementation of Risk Management Activities for products within responsibility.
• Oversight/active involvement in localization and implementation of RMP and additional Risk Minimization Measures in collaboration with other departments, partners, vendors. Ensure that new safety information is available to HCPs in a timely manner (Direct Healthcare Professional Communication) in compliance with local requirements and in cooperation with partner.
• Stay up to date regarding the regulatory requirements in the territory and evaluate their impact on PV activities and responsibilities and take appropriate actions.
• Create and update SOPs relevant to PV activities.
• Create/conduct PV training programs to Medison employees (including new employees) and vendors and ensure maintenance of awareness of drug safety reporting in general.
• Perform review of SDEAs/PVAs with partners and vendors, maintain oversight to ensure safety reporting obligations are defined as necessary. Ensure implementation of the relevant activities in the country cluster under responsibility, where applicable.
• Ensure PV inspection readiness at all times, perform and undergo partners’ audits and regulatory inspections, address follow up actions from findings to non-PV staff and monitor corrective actions.
• Execute or support routine, for-cause, (re-)qualification GVP audits to GxP vendors as well as internal GVP audits in other Medison regions as part of the Global external and internal audit plan respectively, ensuring compliance with regulatory and internal standards.
• Collaborate with EPM and local teams in safety related actions (e.g., withdrawals, recalls), participate in global meetings with partners if requested, provide technical and strategic input, and participate in projects led by EPM teams.
• Manage PV deviations and CAPAs.
• Oversee the Services provided by PV Vendors in cluster countries under responsibility.
• Take part in PV budgeting.