R&D Ancillary Document Team Lead

Job title: R&D Ancillary Document Team Lead

• 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 to get started? As Ancillary Document Team Lead within our Hyderabad Hub, your main responsibilities will be as below:  

Main responsibilities:

• Role includes supervisory responsibilities for a team of ancillary document coordinators. 

• Oversees standards and process efficiencies for submissions and supports effective change.  

• Contributes to revisions/updates to Work Instructions and supportive documents. Trains team members as needed on processes. 

• Oversee onboarding of new ancillary document coordinator 

• Provide forecast and deliveries to Ancillary Document Process Owner 

• Ensuring completion of related on-boarding documentation procedures and documentation.

Direct Ancillary Document Coordination Activities:

• With a continuous process improvement team mindset, efficiently coordinate to deliver top quality and timely ancillary documents intended for submissions related health authorities. 

• High-level oversight of routine ancillary document creation, request and coordination activities. 

•  Confirm that all processes and procedures are being followed, that timelines will be adhered to, and all Sanofi and Health Authority standards are being met based on the request type. 

• Ensure workforce is delivering these regulatory ancillary documents in a timely and high-quality manner. 

• Provide subject matter expertise in ancillary document request types/processes with responsibility for training/mentoring workforce. 

• Support and solve technical issue resolution, as needed. 

• Participate in project teams, working groups, as required. 

Drive Operational Excellence:

• Support a focused, quick acting, flexible and unified ancillary document team; stay up to date with health Authorities changes and trends. 

• Assist in compilation of departmental metrics and performance goals. 

• Strive for continuous improvement and development of systems and procedures. 

• Conceptualize new processes to drive efficiencies. 

• Develop, author and maintain supporting procedural documentation and tools for ancillary document process and request (user guides, work instructions). 

• Utilize new technologies to their highest capabilities, while maximizing team potential via training and development opportunities. 

About you 

Experience:  

• At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences or related areas of study. 

• Experience in the pharmaceutical industry with diverse regulatory experience; including regulatory affiliate experience with a strong technical aptitude with various software/troubleshooting. 

• Demonstrated ability to lead teams and collaborate with functional partners. Able to operate with discretion and confidentiality about sensitive data. 

• Proven ability to use excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization. 

• Ability to manage simultaneous priorities and lead complex projects and timelines in a matrix team environment. 

• Strong attention to detail and accuracy; apply project management skills to appropriate activities. 

• Possess strong knowledge of the drug development process and global regulatory regulations and guidelines. 

• Demonstrated and recognized capacity to identify processes issues, determines the causes and find efficient solutions. 

• Demonstrated leadership abilities with strong negotiating/influencing skills and effective people management. RIM environment and concept 

• At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences or related areas of study. 

• Strong command of the English language, both spoken and written. French or German is a plus. 

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. 

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!