Regulatory Coordinator
Budapest, Hungary Permanent Posted on Dec. 06, 2024 Closing on Mar. 03, 2025Regulatory Coordinator
REPORTS TO:
Global Partner Markets Team Lead - EU
BUSINESS AREA:
Science Hub
JOB PURPOSE
Regulatory Coordinator is responsible for some EU (or Eurasian) markets:
- The coordination of the distributors and/or Third Parties acting on behalf of Sanofi and its subsidiary entities in some EU markets, by providing them with the dossiers to be submitted in these concerned countries with the required guidance and timing and they will provide oversight to ensure the appropriate compliance of their activities as per the Master Service Agreement from a regulatory and medical perspective
- Managing the portfolio of European products (medicinal products (chemically defined and herbal), medical devices, food supplements and cosmetics if applicable) under development and/or marketed products as well as from a medical perspective.
- For global products/projects, they will provide regional Science strategy and are responsible for operational aspects on dossiers´ preparation and submission.
- They will be also responsible to strengthen the regional and local brands by supporting new claims and will be in direct coordination with the global medical teams for the regional execution
KEY ACCOUNTABILITIES
Regulatory Coordinator is responsible for some EU (or Eurasian) markets:
- Manage Distributors/Third Parties to ensure excellent and compliant execution of operations in the concerned markets
- Define, coordinate, and contribute to the preparation of the dossiers and response documents to Health Authority questions within the Science organization for regional and defined multi-regional products/projects.
- Direct Health Authority interaction and communication for European / Eurasian procedures in case needed
- Provide scientific contribution to Risk Management Plans, Periodic Safety Update Reports, Addendum to Clinical and Nonclinical Overview, Core labelling documentation (e.g. Company Core Data Sheets and Core Safety Profiles), etc. for regional and defined multi-regional products/projects
- Provide Science support to policy, external trade association collaboration, and risk management.
- Be accountable for the maintenance of the existing European portfolio, managing the maintenance activities such as renewals, variations, benefit/risk assessments, referrals, discontinuation process, PRAC signals, PBRER/PSUSA etc.
- Ensure compliance of regulatory activities for development and marketed regional products
- Provide scientific support for registration activities in countries outside the Region
- Steer operational excellence coordination and governance within the region to ensure adherence to internal deadlines and KPIs, e.g. monthly validation of events of worldwide CHC medicinal products´ portfolio in accordance with the applicable EU / Eurasian regulations
- Provide regional input for development of the GRPS (Global Regulatory Product Strategy) and ensure timely execution of defined milestones for global development projects as per blue print.
- Follow regulatory changes, competitors’ status and assess potential impact on daily activities and project strategy
- Drive the scientific assessment for the business opportunities from the Innovation Team / Business development
- Oversight of the regulatory data bases and track the missing data in case needed through spontaneous checks and monthly issuing of the KPI reports.
Requirements:
Education
- PhD, PharmD or MD supported by good experience.
Required knowledge and/or experience
- Minimum 2-3 years experience in the Consumer Healthcare or Pharmaceutical industry, in Regulatory Affairs (global, regional, or local)
- Project management experience in the pharmaceutical industry or in an international regulatory environment
- Demonstrated ability to work in a matrix environment and implement operational regulatory excellence
- Comprehensive expert knowledge of and operational expertise in regional pharmaceutical regulations of medicinal products and medical devices as well as food supplements in EU and Eurasia
- Ability to evaluate impact of new regulations within the drug development environment and to lead discussions of the requirements and its impacts within submission teams
Language skills
- Fluent spoken and written English
- A second language is desirable, preferably Russian
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