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...

Responsible for regulatory activity related to clinical section for US, ;EU, WHO, Canada, Australia, New Zealand and South Africa MarketsPreparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelinesEnsure timely preparation of amendments related to bioequivalence to expedite approvalsReview of BE protocol for...

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...

Role & responsibilitiesPreparation and reviewing of CTD and ACTD dossier.Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.Co-ordination with plant for Regulatory compliances.Timely achievement of monthly plan & timely query response.Gap Analysis/Updation of Master data.Review of Change Controls, Stability Protocol,...

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...

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...

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...

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...

Global Regulatory Operations Senior Executive - APACJob Id: 11870City:Navi Mumbai, Maharashtra, IndiaDepartment: RegulatoryFunction: Regulatory Science & Government AffairsEmployee Type: Permanent Full TimeSeniority Level: ExecutiveDescription:ob Summary:The Regulatory Operations Specialist will be responsible for managing and executing regulatory...