Expert Regulatory Writer

500! The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies, ranging from Phase I to IV Clinical Study Reports to regulatory submission documents (e.g. Clinical Summaries, Clinical Overview, Briefing Books, answers to Health Authority...

About the Job">We are seeking a highly skilled Regulatory Writer Expert to join our team at Sanofi Global Hub in Hyderabad, India.">As a key member of our medical writing team, you will be responsible for creating high-quality safety and clinical documents, including Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports, and product alerts.">Your...

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...

Job OverviewWe are seeking an experienced Medical Regulatory Writer to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT. The successful candidate will be responsible for creating high-quality clinical and safety documents for submission to regulatory authorities.About the RoleWrite and/or edit complex Clinical...

About the RoleAs a Global Regulatory Writing Expert at Lifelancer, you will play a crucial role in authoring and gaining approval of scientific and regulatory submission documents that comply with global regulatory standards.Maintaining key business relationships with cross-functional product team members is essential for success in this position. This role...

Job Title: Regulatory Medical Writer SpecialistJob Type: Full-timeSalary: $120,000 - $150,000 per yearLocation: Hyderabad, Telangana, IndiaAbout Company: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.About Job: We are seeking an experienced Regulatory Medical Writer Specialist to join our team. As a key member of our medical writing...

Job OverviewThe role of a Regulatory Writer at Lifelancer involves creating high-quality clinical and safety documents for submission to regulatory authorities. As a medical writer, you will be responsible for writing, editing, and reviewing documents under guidance to support marketing authorization applications, renewals, and maintenance activities.

Job OverviewIn this role, you will work as a Senior Regulatory Writer creating high-quality medical documents for the pharmaceutical industry. The ideal candidate has 5+ years of experience in regulatory writing and is proficient in English.

About the Role">">The Senior Medical Regulatory Writer will be responsible for creating high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports, and product alerts.">Main Responsibilities:">

**MakroCare** is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical,- Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New- Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,- Medical/Scientific Support and Emerging Region Expansion**Job...

We are seeking a Regulatory Affairs Expert to join our team at Lee Pharma Limited.This individual will be responsible for managing DMF filings, responding to queries, ANDA query responses, laboratory audit preparation, and supporting/coordinating nature to other departments.Experience in process development, optimization, identification of critical process...

Job Overview:Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We are seeking an experienced Senior Regulatory Consultant with EU market experience to join our team. The ideal candidate will have a strong background in CMC authoring and reviewing, specifically Module 3, and excellent...

About the JobAs a Medical Regulatory Writer with our team at Sanofi Global Hub, you will play a crucial role in creating high-quality safety and clinical documents that meet regulatory requirements.ResponsibilitiesDevelop and edit medical sections of Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports, and other critical documents.Collaborate...

Overview: - This role involves supporting the Regulatory Affairs team by serving as a Discipline Approver, ensuring compliance with regulatory standards for raw material specifications. Located within the Mexico Business Services or Hyderabad Business Services, you will play a key part in maintaining adherence to regulations within the designated business...

We are seeking a highly skilled Global Regulatory Writing Manager to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT. This is a full-time position based in Hyderabad, Telangana, India.About the Job:The successful candidate will maintain key business relationships with cross-functional product team members, serving as...

**Who We Are**: Base8 provides technology and business consulting services to companies throughout the US and Canada under the XOverture, Cure8, and Forte brands. We like to work with businesses that are serious about scaling, risk management, and developing mature processes - ones that are looking for a modern, sophisticated, trustworthy, friendly,...

**MakroCare** is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical,Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a NewDimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,Medical/Scientific Support and Emerging Region Expansion **Job...

**SOP Writer - Remote** **Who We Are**: Base8 provides technology and business consulting services to companies throughout the US and Canada. We like to work with businesses serious about scaling, risk management, and developing mature processes - those looking for a modern, sophisticated, trustworthy, friendly, high-quality (yet still affordable)...

Company Overview: Lee Pharma Limited is a dynamic and growing pharmaceutical company that values innovation and excellence in its laboratory operations.Salary: ₹1,000,000 - ₹1,600,000 per annum, depending on experience.Job Description: The Laboratory Regulatory Compliance Expert will be responsible for ensuring that our laboratory operations meet the...

At Syneos Health, we're accelerating customer success by harnessing the power of innovative clinical, medical affairs, and commercial insights. Our fully integrated biopharmaceutical solutions organization brings the customer and patient to the forefront of everything we do.We're committed to simplifying and streamlining our work processes, making Syneos...