Study Start-up and Regulatory Submission Manager

Study Initiation CoordinatorThe Study Initiation Coordinator plays a pivotal role in the initiation of clinical trials, overseeing and managing all aspects of study start-up. This includes regulatory submissions, ethics committee approvals, and site activation.This position requires the ability to develop and implement effective start-up strategies to...

Company DescriptionExpecto Health Science is a leading Clinical Research Organization based in Singapore, specializing in Clinical Development, Data Management, Medical Writing, Regulatory, and Pharmacovigilance services in the Asia Pacific Region. The company offers tailored solutions to a diverse client base, including global Pharma clients and...

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...

Key Responsibilities Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements. Review technical documents from manufacturing sites, including: Specifications Batch Manufacturing Records Process & Analytical Validations Batch Analysis Data Stability Data Compile initial dossiers (Modules 2 & 3)...

G&L Scientific have an immediate need for Regulatory Labelling Specialists to join our team in IndiaPlease only apply if you can start immediately.This role can be based in our Mumbai or Hyderabad Office Key Responsibilities: Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations Collaborating with...

Regulatory Affairs Manager Job DescriptionThe ideal candidate for this role will be responsible for ensuring regulatory compliance across the US, European and UK market.This position requires a highly skilled and experienced professional who can manage complex drug approvals, comparability studies, bioequivalence challenges, and formulation complexities....

Job Summary:We seek an accomplished Regulatory Affairs Specialist to serve as Assistant Manager / Manager Regulatory Affairs – Complex Products.The ideal candidate will possess a minimum of 10+ years' experience in the pharmaceutical industry with expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU markets.Preparation and...

G&L Scientific have an immediate need for Regulatory Labelling Specialists to join our team in India Please only apply if you can start immediately. This role can be based in our Mumbai or Hyderabad Office Key Responsibilities: Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations Collaborating with...

Job Title: Regulatory Affairs ManagerAbout the RoleThis is an exciting opportunity for a highly skilled Regulatory Affairs professional to join our organization and contribute to the success of our team. We are seeking an experienced Regulatory Affairs Executive to lead our regulatory strategy, manage regulatory submissions, and maintain strong relationships...