Senior Regulatory Affairs (CMC) Writer

Job title: Senior Regulatory Affairs (CMC) Writer

• Location: Hyderabad

About the job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.  

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. 

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in the area of regulatory compliance, maintenance of product licenses and technical writing of CMC documents. The team members of the global M&S Services Hub will act as partners in carrying out tasks and fulfilling responsibilities to support global quality activities with a focus on technical writing.

Main responsibilities:

Regulatory Intelligence & Requirements​ :Communicate to sites the information on new regulations​ .List the CMC changes required on the CMC documentation impacted by the new CMC regulations​ .Oversees the implementation of new regulations with sites​

CMC Document Management​ :Write CMC regulatory dossiers for single non-complex changes, Renewals and Annual Report​ .Write & approve local CMC documents (e.g. QOS)​​

Report issues in implementing quality technical writing processes to ICM

Share best practices among the pool of technical writers and ensure consistency in technical writing activities

Regulatory Compliance​: Support sites in the regulatory compliance maintenance by sourcing and compiling the latest CMC dossiers and Post-Approval Changes from the company databases ​.Track the due dates for Site registration and oversee progress by sites​ .Check and approve the product designation across manufacturing and regulatory ​

TransversalActivities​ :Perform local training for sites to CMC regulatory requirements and IT tools​ Contribute to Global Quality reporting (KPIs) ​.Focal point for 3rd party customer regulatory request​

About you:

Experience: min. 4 years of experience in CMC regulatory affairs (Worldwide regulations knowledge), preferably in biotech/Vaccines, as well as experience in a transversal position within a global company interacting with multiple functions/countries. Experience in pharmaceuticalmanufacturingortestingactivitiesisrequired​

Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments

Technical skills:theoretical knowledge in Chemistry Manufacturing & Control (CMC),biotechnological manufacturing operations(for VX & SPC only), Regulatory Registration and Maintenance, GxP and health-related regulations​. Abilityinwriting technical documents and reports​, good organization and planning skills​, sense ofpriorities and teamwork ability​ and cooperatetransversally​

Education: Pharmacist or Chemical/BioChemical Engineer having strong regulatory knowledge (CMC), in biotech and vaccine regulations​ (for VX & SPC only)​

Languages: Verbal and written fluency in English​

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, whether it’s through a promotion or lateral move, at home or internationally.
• 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.