BLA Regulatory Publishing Specialist

Key Responsibilities: Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing . Compile, format, and publish regulatory documents according to global health authority requirements. Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes. Perform QC of eCTD submissions,...

Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform QC of eCTD submissions, including...

Key Responsibilities: - Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing. - Compile, format, and publish regulatory documents according to global health authority requirements. - Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes. - Perform QC of eCTD submissions,...

Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...

Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait.We started in 1984 with a modest investment, 20...

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

Job Overview:The Regulatory Compliance Specialist plays a pivotal role in ensuring the organization's products comply with international regulatory guidelines and country-specific requirements. Key responsibilities include preparing, reviewing, and maintaining regulatory documents to guarantee compliance. This involves close coordination with internal teams...

Job Description Job Overview Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client sites. Summary Of Responsibilities These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and...

We are seeking an experienced Regulatory Specialist with strong expertise in the power sector. The candidate will be responsible for handling ARR filings, tariff determination, petitions, and compliance with regulatory frameworks . The ideal professional should have a proven track record of working with Regulatory Commissions/Power Utilities and...