R&D Ancillary Document Coordinator

Job title: R&D Ancillary Document Coordinator

• Location: IN / Hyderabad

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. Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready?

As Ancillary Document Coordinator you will apply regional expertise in requesting all ancillary document types intended to be submitted for the GRA portfolio, from standard to complex.  The Ancillary Document Coordinator is responsible for the operational ancillary document planning request, ability to prioritize workload, and negotiate timelines with key stakeholders.  They 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.

• 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

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

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

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

• Expert knowledge of regional submission standards and specifications. Expertise in document management environments/systems.

• Maintain independent abilities to learn quickly and adapt to new technologies/environments. Self-starter, who is motivated.

• Ability to work across cultures. Ability to identify and communicate opportunities for process improvement.

• Strong attention to detail and accuracy. bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience

• High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.

• Strong command of the English language, both spoken and written.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, with international mobility options.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and supports your wellbeing.

• 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.

• Play a pivotal role in participating to high quality dossiers to be submitted to various Health Authorities.

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  PursueProgress. 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.
  

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