Company Jobs

Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting. Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.

Develop, optimize, and publish high-quality analytical methods using high-field NMR and qNMR applications; publications may include white papers, application notes, or journal articles ; Acquire high resolution qNMR spectra and implement structural elucidation for obtaining chemical structural information to develop QM spectral analysis models

Work closely with cross-functional teams including preclinical, clinical, and regulatory teams to guide decision- making and project direction. Utilize software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus Simcyp, PK-Sim, and other similar platforms for M&S.

Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.

Ensure on time analysis of Finished products and raw materials for required product and projects. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.

Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.

To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation. To carry out stability studies of projects as per the project requirement and regulatory guidelines.

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.