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, including...

Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Hands-on experience with Docubridge and Lorenz Validator for regulatory submissions.Strong background in Regulatory Publishing with knowledge of global regulatory requirements (FDA, EMA).Experience in Life Sciences / Pharma regulatory...

Job Description Title: Junior Submission Publisher Business Unit: Regulatory Operations Global Regulatory & Business Continuity Innovative Medicines Job Grade Senior Executive / G11B Location : Mumbai (preferred) / Gurugram / Vadodara Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you...

Purpose: Regulatory Submission Publisher will be responsible for assisting in the compilation, formatting, publishing, and validation of regulatory submissions in eCTD and non-eCTD formats. The role will provide exposure to global regulatory submission requirements for agencies such as US FDA, EMA, Health Canada, MHRA, and others.Responsibilities:• Assist...

Job Description We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: Plan and manage development of high...

Job Description Title: Senior Submission Publisher Business Unit: Regulatory Operations Global Regulatory & Business Continuity Innovative Medicines Job Grade G10 / Manager Location : Mumbai (preferred) / Gurgaon / Baroda Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...

Job Description - Around 7-10 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets. - Good understanding of regulatory framework, including regional trends, for various types of applications and procedures. - Lead and / or...

Job Description Company Description Ethereal Assurance Pvt Ltd is based in Lucknow, Uttar Pradesh, India. Located in Sector B, LDA Colony, the company is known for its dependable services. The company is situated in a prime location in front of SKD Hospital, making it easily accessible for employees and clients. Role Description This is a full-time,...

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...