Regulatory Affairs Expert - Medical Governance

Regulatory Affairs Expert - Medical Governance

• Location: Budapest, Hyderabad
• 60% remote working
• Job type: Permanent and Full time

About the job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

As Regulatory Affairs Expert - Medical Governance you will be working with with Regional Medical Planning Lead of the region in partnership Medical management in supporting the implementation of medical governance guidance principles and ensuring compliance with Sanofi global and/or local standards. Providing support in operationalize Strategy and Key processes/Systems related to MedicalAffairs activities in line with Sanofi standards with and across teams. You will have a complete overview of local tools & processes to enable smooth implementation of Group led initiative.

• Manage and or improve the Governance standards by establishing frameworks, guidelines, policies, and processes.
• Ensure Regional Medical Governance Database (detailed information by country) is maintained forcountries in region.
• Support strategic and operational guidance in a plain language for MA activities.
• Act as a subject matter expert for Governance and compliance aspects of region and educate or train other stakeholders on the process whenever required.
• Support in identifying potential areas to harmonize and create efficiencies across countries in the region and work closely with local & global teams to address if any gaps identified.
• Participate in the creation of new processes & tailoring of existent ones in accordance with business imperatives and compliance standards.
• Support Medical Affairs team in cross functional projects to continuously improve Sanofi standards, policies, guidelines, and systems.
• Identify and escalate quality and compliance risks related to assigned regions and propose mechanisms to mitigate risks.
• Participate in internal controland E&BI monitoring exercise, audits and inspections.
• Works on CAPA resolution following audit or inspection findings and ensures completion.
• Supports Country site visits and Third-Party Inspections to ensure localimplementation of Company Medical Standards andRegulatoryrequirements.
• Share the best practices across the region.

About you

Experience:

• Proven experience in medical domain including operational experience in QA, Regulatory, EBI & international regulations & standards
• Experience with Regulatory Submissions including Investigational New Drug applications, New Drug Applications, Biologics License Applications in the US and Knowledge of Marketing Authorization Application procedures in Europe

Soft and technical skills:

• Thorough understanding of regulatory requirements and guidelines for the US (FDA) and Europe (EMA)
• Understanding of regulatory requirements for different phases of clinical trial, local and international regulations related to medical affairs
• Self Starter with good communication skills and the ability to work transversally across departments and functions
• Strong administrative and organizational skills in complex set ups with agility.
• Basic MS Office skills, Smartsheet & Project Management

Education: Bachelor/Higher Degree or equivalent experie

Languages: Excellent knowledge of English language (spoken and written)

Pursue Progress. Discover Extraordinary.

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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