PhD, MS, BS in relevant functions in the Pharmaceutical, Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities.
Familiarity with high-performance organizational tools and a strong understanding of digital manufacturing processes, computer system validation requirements, and quality management within biologics production and quality.
Bachelors degree in Life Sciences, Pharmacy, Medicine, or related field, with a keen interest in medical writing, clinical research, and drug development processes. Excellent written and verbal communication skills, with the ability to translate complex medical and scientific information into clear, concise, and engaging content tailored to diverse audiences.
Glenmark Pharmaceuticals Limited is a research‐led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus in the therapy areas of Respiratory, Dermatology and Oncology.
Experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic & controlarea operation, documentation, both SVP and LVP manufacturing etc.
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.
On the 50th Anniversary year of the Indian Independence, the Government of National Capital Territory of Delhi has instituted the Delhi Subordinate Services Selection Board. The Board has been incorporated with the purpose of recruiting capable, competent, highly skilled individuals by conducting written tests, professional tests and personal interviews wherever as desired.
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.