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Regulatory Affairs (CMC) Writer - MSAT

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Sanofi

Oct 16

Applications are closed

  • Job
    Full-time
    Senior Level
  • Product
  • Hyderabad, +1

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Requirements

  • 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

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.

FAQs

What is the job title for this position?

The job title is Regulatory Affairs (CMC) Writer - MSAT.

Where is the location for this job?

The location for this job is Hyderabad.

What are the main responsibilities of this role?

The main responsibilities include document development coordination/preparation, technical/regulatory documentation and communication, and review and approval management.

What is the required experience for this position?

The position requires 5 years of experience in the medical device and pharmaceutical industry.

What soft skills are preferred for this role?

Preferred soft skills include problem-solving, attention to detail, good organizational skills, the ability to work collaboratively with cross-functional teams, and strong analytical abilities.

What technical skills are necessary for this job?

Necessary technical skills include experience in regulatory document preparation, CMC submissions, and interaction with health authorities, alongside strong written and verbal communication skills.

What educational background is required for this position?

A Bachelor’s degree in engineering or a related field is required.

What language proficiency is expected for this role?

Excellent English communication and technical writing abilities are expected.

What are some benefits of working at Sanofi?

Benefits include a supportive team environment, opportunities for career growth, a rewarding compensation package, and health and wellbeing benefits including high-quality healthcare and parental leave.

Is experience working with health authorities important for this role?

Yes, proven experience in interaction with health authorities is an important requirement for this position.

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

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