Regulatory Affairs project coordinator - Medical Governance

• Location: Budapest

• 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?

• 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 for countries 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 control and 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 local implementation of Company Medical Standards and Regulatory requirements.

• 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)

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment

• Work from an "Office of the Year 2023" award winner with flexible home office policy

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks

• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

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