German speaking Ancillary Document Coordinator Budapest

German speaking Ancillary Document Coordinator
Budapest
Budapest, Budapest, HU

• Job title: Ancillary Document Coordinator
• Location: Budapest, Hungary
• Job type: Permanent, full-time
• Hybrid working
  
   

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

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?

Join our global regulatory affairs team as an Ancillary Document Coordinator and you’ll help us request all ancillary document types intended to be submitted for the GRA portfolio, from standard to complex. You’ll be responsible for the operational ancillary document planning request, ability to prioritize workload, and negotiate timelines with key stakeholders.   You’ll also partner closely with Vendors to execute the preparation and / or request of the ancillary Documents according to the planning.

Main responsibilities:

-       Applies project management skills and regulatory knowledge for ancillary document request and tracking activities.

-       Applies expert understanding on ancillary document request per country.

-       Advise stakeholders on ancillary document regulation and guidance to ensure an appropriate understanding of submission requirements from a cross-functionally perspective.

-       Creation and maintain templates for specific ancillary document requests (e. g. CPP) for assigned portfolio to ensure high quality and timely submission delivery aligned to both Sanofi and applicable Health Authority standards.

-       Interact with German HAs to request CPPs or GMP certificates

-       Draft + Review CPP forms.

-       Work in coordination with vendors to follow ancillary document requests and shipping.

-       Work in coordination with vendors and stakeholders to maintain ancillary document tracking tool.

-       Upload ancillary documents in Vault RIM.

-       Complete appropriate metadata for ancillary documents in Vault RIM.

-       Manage ancillary documents in Vault RIM.

-       Partner with GRA and Digital functions as SME for current processes/data/technologies, as well as evaluating and implementing new/emerging technologies and requirements.

About you

Experience:

o    Relevant professional experience in Pharmaceutical Industry, with direct experience in Regulatory Operations and/or Regulatory Affairs

o    High degree of knowledge regarding standards and requirements of regulatory dossiers is required.

o    Expert knowledge of regional submission standards and specifications.

o    Maintain independent abilities to learn quickly and adapt to new technologies/environments.

Soft Skills:

o    Self-starter, who is motivated.

o    Ability to work across cultures.

o    Ability to identify and communicate opportunities for process improvement.

o    Strong attention to detail and accuracy.

o    Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.

Technical skills: 

o    Proficiency working in RIM systems, MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.

o    Expertise in document management environments/systems.

Education: 

o    Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience

Language(s):

• Strong German and English skills (verbal and written), ability to exchange fluently in a global environment

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 and check out our Diversity Equity and Inclusion actions at sanofi.com !

Discover our Code of Conduct , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

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