R&D Ancillary Document Coordinator
Hyderabad, India Permanent Posted on May. 02, 2025 Closing on Jun. 30, 2025Job 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.
undefined
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.
Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!
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 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
You have not viewed any jobs yet.
You have not saved any jobs yet.
Hubs
From Bogota to Budapest, Kuala Lumpur to Hyderabad – it’s your skills that help the Sanofi world go round. With a role in one of our Hubs, you’re right at the heart of our global transformation, as we fearlessly work together to cut the time it gets new treatments to patients. By making the most of your creativity and bringing your unique self you’re supportingyou’ll help others to perform at their best. Let’s make the discoveries that’ll change lives.
Find out more about this location
Experience possibility
-
-
Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
-
Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
-
Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
-
Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
-
Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
-
Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
-
Emmanuel
Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.
-
Dimitrije
Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.
-
Ziv
Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.
-
-
When you grow, we all grow
We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.
-
Build a career with purpose
Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.
-
Bolder, better futures
Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.
-
Our locations
We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
Sanofi at Cambridge Crossing
Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.
-
Why Sanofi
Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.
-
Our people & culture
We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.
-
Sanofi's Postdoctoral Program
Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.
-
Physician Careers at Sanofi
At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Meet Azer Hallabi, Project Manager, Global Regulatory Affairs
Discover the dynamic world of regulatory affairs with Azer Hallabi, Project Manager in Global Regulatory Affairs at our Budapest Hub.
-
Meet Nils Libert, Associate Scientist in R&D
Meet Nils Libert, an Associate Scientist contributing to groundbreaking research in R&D, Belgium.
-
Meet Orsolya Dina, Receivables & Revenue Team Lead
Follow Orsolya Dina’s inspiring journey as she embraces new opportunities for growth and advancement.
-
Meet Stefanie Van Poucke, GMP QA Head
Join Stefanie Van Poucke as she navigates the world of Quality Assurance, leading GMP QA efforts in R&D, Belgium.
-
Meet Robin, Digital Product Owner, Belgium
Dive into the digital world with Robin Meuris, as he discusses his role as a Digital Product Owner in Belgium.
-
Meet Ádám Honvéd, Product Owner Process Analytics
Step into the world of analytics with Ádám Honvéd as he shares his journey as a Product Owner for Process Analytics at our Budapest Hub.
-
-
-
-
Dachuan Li: From Operating Room to Medical Education
Dachuan Li traded his surgical scrubs for a career bridging science and healthcare as a Medical Science Liaison (MSL) in China.
-
Julien Guyomard: From Cars to COVID to Canada
How seizing opportunities built a global career for Julien Guyomard. Julien's career in communications has taken him from the production lines of French car factories to the global stage of the Paris 2024 Olympics and finally to leading communications in Canada.
-
Vincent Dufauret: Embracing the Unexpected - Building a Versatile Career
Vincent Dufauret, currently Global Digital Communication Project Lead, reflects on his diverse career journey. He shares the insights he wishes he'd understood from the beginning.
Join our
talent community
What could we achieve together? Every Sanofian works on projects that truly make a difference to people’s lives.
Sign up today and discover our latest opportunities as soon as they’re available.