Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications to support business and product development decisions.
With over three decades of leadership in pharmaceutical innovation and quality, Baroque Pharmaceuticals has evolved into a premier backend global partner. From formulation R&D to large-scale commercial manufacturing, we offer end-to- end solutions tailored to meet the dynamic needs of global healthcare markets.
Prepare, compile and review regulatory submissions for ROW markets. Prepare CTD/ACTD dossiers for non-regulated markets. Ensure timely dossier submissions and respond to regulatory queries.
Bachelor degree in Medical, Life Science or other healthcare related majors. Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Medtronic
Risk Evidence Writer inputs into of all aspects of the Reckitt global signal management process, including signal surveillance for medicines, medical devices, cosmetics and other Reckitt products.
Support data collection for regulatory and internal reports by compiling and reconciling data from multiple source systems and reporting tools within organization.
Bachelor or Master Degree -MS/MA- Science Field. Support protocol amendments, Investigators Brochure updates, and Informed Consent Form revisions. Maintain Trial Master File, TMF and ensure timely filing and quality control of essential documents
Bachelors degree in pharmacy or similar medical education. Pharma experience with regulatory focus in a multi-national. Regulatory Affairs Manager, you will play a critical role in ensuring patients continue to have access to innovative healthcare solutions. Boehringer Ingelheim