October 15, 2024

Sanofi US

OTHER

Regulatory Affairs (CMC) Writer - MSAT

Job title : Regulatory Affairs (CMC) Writer - MSAT

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:

Document Development Coordination/Preparation: Establish document timelines with project team. Work with cross-functional SMEs to draft and agree technical document outline.
Technical /Regulatory Documentation & Communication: Write general technical background and standard text for validation documents and CMC dossiers. Ensure documentation aligns with Sanofi requirements, industry standards and best practices.
Review and Approval Management: Collaboration during the peer review process. Revision of standard part of documents based on review.

About you:

Experience: 5 years’ experience in a medical device and pharmaceutical, industry
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: Proven experience in regulatory document preparation, CMC submissions and interaction with Health Authorities. Strong communication skills, particularly written, but also including email and telephone communication with technical and non-technical personal in different countries.
Education: Bachelor’s degree in engineering or a related field.
Languages: Excellent English communication and technical writing abilities

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.