Global Regulatory Submission Publishing Associate

Bristol Myers Squibb is a leading global biopharmaceutical company that transforms patients' lives through science and innovation.We are committed to creating a diverse and inclusive work environment where our employees can grow and thrive.As a Senior Submission Specialist at Bristol Myers Squibb, you will play a critical role in delivering Health Authority...

**Job Summary**: **Key Responsibilities**: - Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW. - Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch. - Manage and track the status of submissions and respond to regulatory agencies'...

Description:Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standardsReport directly to the Team Manager on all team and client issues, project work, project deliverables associated timelines, ensuring SLAs are satisfied and deliver reporting –...

**Job Summary**: **Key Responsibilities**: Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW. Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch. Manage and track the status of submissions and respond to regulatory agencies' queries...

**Summary**: Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions. **About the Role**: **Major accountabilities**: -...

Position:Associate RAPublishingLocation:Hyderabad Madhapur Telangana500081ExperienceRequired: 13YearsEducation:Bachelor s Degree in Life Sciences or relatedfieldMarkets:US/UK/EU/ROWJobSummary:We are seeking adetailoriented and proactive Associate Regulatory Affairs (RA)Publishing with 13 years of experiencein regulatory submissions across global markets...

Job Summary:Bristol Myers Squibb is seeking a highly skilled Regulatory Submission Specialist to join our team. This role plays a critical part in the submission of regulatory documents to health authorities.About the Job:We are looking for an individual with 3+ years of relevant submissions experience, preferably in a science or technology field. The...

Bristol Myers Squibb is a global biopharma leader driven by a mission to transform patients' lives.Estimated Salary: $120,000 - $180,000 per yearAbout the RoleWe are seeking an experienced Regulatory Submission Manager to join our team in Hyderabad. The successful candidate will be responsible for managing and coordinating the timely, compliant, and accurate...

Transformative OpportunityBristol Myers Squibb is a pioneering global biopharmaceutical company that pushes the boundaries of medical innovation. Our mission is to deliver transformative medicines that change the lives of patients worldwide.We are seeking a highly skilled Regulatory Submission Expert to join our team in Hyderabad, India. This exciting...

Transformative Regulatory Solutions at Bristol Myers SquibbBristol Myers Squibb is an innovative leader in the pharmaceutical industry, dedicated to creating a brighter future for patients worldwide. Our mission is to deliver transformative medications that improve lives and expand possibilities.Salary Range: $80,000 - $120,000 per yearWe are seeking a...

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

Transforming Patients' Lives with Innovative SolutionsBristol Myers Squibb is an organization where unique and interesting work happens every day. We are a global hub focused on helping patients prevail over serious diseases by building sustainable and innovative solutions.About the RoleThe Senior Submission Specialist plays a crucial part in supporting the...

Job Description: • Successfully meet/ complete training milestones relevant to the position held. • Familiarity with FDA, GCPs, ICH guidelines, Life Sciences & Pharmaceutical industry • Familiarity of health authority procedures / guidance regarding electronic submissions • Perform submission publishing, assembly, and distribution activities...

Position Title:Associate, Regulatory AffairsReports To:Director, Regulatory AffairsLocation:Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...