Regulatory Affairs Officer

Responsibilities - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions - Compile...

Regulatory Affairs Associate Manager Location: Remote Duration: 7 months RESPONSIBILITES: - Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations - Participate in validation of marketing campaigns and review of associated materials - Approve packaging...

**Regulatory Affairs Associate** - Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. - Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...

Hyderabad **EMAIL** I **Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India** Diagnostics compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our...

Regulatory Affairs ManagerAs a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements in the pharmaceutical industry. Your expertise in document management, regulatory compliance, strategy and planning, project management, lifecycle management, coordination and communication, process optimization, and...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

Job Description:">The Vigilance Specialist is responsible for managing product complaints, ensuring adherence to both internal procedures and external regulations.Determine regulatory reporting requirements and manage Health Authority Requests in compliance with EU MDR 2017/745 and other relevant global regulations.Facilitate and oversee complaint...

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the the regulatory and scientific project team members (regulatory affairs, eTMF operations, medical writing, pharmacovigilance, and medical monitoring). The RPA properly manages personal timelines and workload distribution between short term and long term...

**MAIN RESPONSIBILITIES**: Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). Define document writing strategies. Define positions for variation folders. Assess the compliance of...

Job Title: Senior Medical WriterJob Role:Lead and mentor a team of medical writers.Manage medical writing activities for individual studies, ensuring projects are completed on time.Responsibilities:Project Management:Serve as a project lead for assigned writing projects.Manage medical writing activities across departments with minimal supervision.Mentor...