Study Start-up and Regulatory Submission Manager

Position Requirements:● 1 to 2 years of experience in Editorial, Project Management, or Operations working in a high-volume, process-oriented environment with a focus on online contentdevelopment, preferably in a medical communications agency, pharmaceutical company, or pharmaceutical advertising agency● 1 to 2 years of experience submitting promotional...

About the Company:Headquartered in El Segundo, Calif., Internet Brands is a fully integrated online media and software services organization focused on four high-value vertical categories: Health, Automotive, Legal, and Home/Travel. The company's award-winning consumer websites lead their categories and serve more than 250 million monthly visitors, while a...

RESPONSIBILITIESBook-in, Data Entry and Quality Reviewer of ICSR in Argus databaseICSR Global Submission (Timelines and Submission Process)Vendor ManagementSOP training in department as and when neededDESIRED SKILLSGood knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines.Good knowledge about timelines and submission process of...

Role & responsibilities :Should be well conversant with IRAC, Exposure, Large exposure norms, Resolution Plan Implementation, Sensitive sector monitoring, etc.Exposure in preparation of DSB, CRILC, PSL, MSME, SLBC, Defaulter, NPA, Bureau reporting (CIBIL), NeSL submission, Quarterly disclosure preparation, Risk Based Supervision submission, Potential NPA...

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...

Summary To write review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications To provide authoritative documentation-related consultancy to other line functions To coach mentor and train less experienced writers Major accountabilities To author ...

One of our client based at Mumbai (Reputed MNC Company) is looking for below positionsRole & responsibilities1. Asst Manager / Manager/Sr. Manager - Biologics Regulatory Affairs (Clinical Trials)-2 positionsJob Location: Govandi (East ), Mumbai (alternate Saturday working)Desired Qualification: M.Pharm/B.PharmDesired Work Experience: 5-10 yearsJob...

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...

ob Summary:The Regulatory Operations Specialist will be responsible for managing and executing regulatory strategies, submissions, and compliance activities across the Asia-Pacific (APAC) region. This role ensures that products meet all regulatory requirements for market access, lifecycle management, and post-market surveillance. The position involves...

Role Overview: As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related...