Regulatory Medical Writer Mumbai Suburban

Regulatory Medical Writer Mumbai Suburban

We are looking for a highly skilled Regulatory Medical Writer with 1 to 6 years of experience to join our team in Mumbai. The ideal candidate will have a strong background in regulatory affairs and medical writing, with excellent communication and analytical skills.

Roles and Responsibility
Develop high-quality regulatory documents, including clinical study reports, marketing authorizations, and other related materials.
Collaborate with cross-functional teams, including regulatory affairs, product development, and clinical operations.
Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and compliance with regulatory requirements.
Stay up-to-date with changing regulatory requirements and guidelines,



ensuring timely updates to internal stakeholders.
Provide training and support to junior writers on regulatory affairs and medical writing best practices.
Participate in the development of new regulatory strategies and initiatives, leveraging expertise in regulatory affairs and medical writing.

Job Requirements
Strong understanding of regulatory affairs, including FDA, EMA, and other global regulatory requirements.
Excellent writing, editing, and communication skills, with the ability to convey complex information clearly and concisely.
Ability to work independently and collaboratively as part of a team, demonstrating flexibility and adaptability.
Solid analytical and problem-solving skills, with attention to detail and the ability to meet deadlines.
Experience with regulatory document management systems, such as TrackWise or similar tools.
Familiarity with Positive Clinical Practice (GCP) principles and regulations governing clinical trials.

The original job offer can be found in Kit Job:
kitjob.in/job/177917707