7 Regulated Markets Jobs

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory.Role & responsibilities Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Maste...

As a Sales and Business Development professional with 6 to 10 years of experience in Regulated markets, particularly in North America and/or Europe, your role will involve the following key responsibilities: - Interacting with customers to understand their commercial requirements and new development pipeline - Identifying new customers in the region to expand market presence - Preparing annual budgets and working towards achieving them - Coordinating with internal cross-functional teams to ensure timely addressal of all technical requests - Providing monthly and quarterly forecasts to Planning & Operations - Working on MIS and preparing inputs for monthly, quarterly, and annual reviews The q...

As an experienced professional with over 10 years in Solid Dosage formulation for Regulated Markets, you will play a crucial role in the development and manufacturing of pharmaceutical products at our company. Your expertise in this area will be essential in ensuring the quality and compliance of our products for regulatory approval. Key Responsibilities: - Develop and optimize Solid Dosage formulations for Regulated Markets - Conduct thorough research and analysis to ensure product efficacy and safety - Collaborate with cross-functional teams to meet project timelines and goals - Evaluate and improve existing formulation processes for efficiency and cost-effectiveness - Stay updated on indu...

You should have 6 to 10 years of experience in Sales and Business development in Regulated markets, preferably North America and/or Europe. Your main responsibilities will include interacting with customers to understand their commercial requirements and new development pipeline, identifying new customers in the region to expand market presence, preparing annual budgets and working towards achieving them. You will also need to coordinate with internal cross functional teams to ensure timely addressal of all technical requests, provide monthly and quarterly forecasts to Planning & Operations, work on MIS, and prepare inputs for monthly, quarterly, and annual reviews. The qualification require...

Pharmaceutical Sourcing of Formulations, Excipients, Packing Material etc. for Regulated markets of USA, Europe, Australia, Latin America. Coordination with Mktg, R&D, Regulatory QA/QC, New Product Development etc. Vendor management for suppliers Required Candidate profile 3 to 12 yrs exp. in Strategic Sourcing for NPD / R&D sourcing for the regulated market projects, Globally, in a leading Pharmaceutical Company Vendors management, Logistics etc. Working on ERP System

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory. Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.