| |AUGUST 20239The Indian pharmaceutical industry is now looking for talent in regulatory departments, as vacancies at the mid and senior levels continue to be a challenge. The workforce here is responsible for managing the protocols required to submit newer submissions to health authorities and to comply with the increasingly complex regulations across various markets."A strong regulatory team in the company allows both faster progress towards commercialisation of products and fewer encounters with issues of non-compliance, giving companies a competitive advantage," says Prakash HS, vice president pharma & life sciences, WalkWater Talent Advisors. A senior talent must have extensive technical and product knowledge of medical product development, as well as familiarity with US FDA regulations. This is not possible without specialised training and on-the-job experience."To facilitate the growth of the Indian pharma, the regulatory affairs function in the pharma organizations will play a major role and the importance of this function has gone up significantly over the last few years, he added.Moreover, we see the regulatory affairs function is facing a massive change as it is expected to rapidly digitize and transform the organization. Pharma companies opt for candidates with Master's degree in pharmacy while hiring for regulatory affairs function at the entry levels roles.For mid and senior levels along with the Master's degree, companies expect the candidates to have in-depth knowledge and experience in regulatory submissions, product registrations and complete understanding of the guidelines of each regulatory body be it US FDA, UK MHRA, etc. POGranules India Limited, a vertically integrated and rapidly growing Indian pharmaceutical company, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company based in Chantilly, Virginia, USA, has successfully completed the United States Food and Drug Administration (FDA) Post-marketing Adverse Drug Experience (PADE) Inspection for all of its entities in the United States, including Granules India Limited. The inspection ended with no observations.From July 31, 2023 to August 3, 2023, Granules Pharmaceuticals Inc. (GPI) was inspected. This inspection focused on Granules' PADE surveillance, receipts, evaluations, processing, and reporting system for globally marketed drug products.Granules India's fourth FDA audit since March has resulted in zero observations, demonstrating the company's unwavering commitment to ensuring the highest level of patient safety and product quality.Granules India Limited, founded in 1991, is a vertically integrated, fast-growing Indian pharmaceutical company with best-in-class facilities and a commitment to operational excellence, quality, and customer service.Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain ­ from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs), Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK. POINDIAN PHARMA IS ON THE LOOKOUT FOR REGULATORY TALENT, AS VACANCIES AT THE MID & SENIOR LEVELS REMAINS A CHALLENGEGRANULES PHARMA COMPLETES US FDA POST-MARKETING ADVERSE DRUG EXPERIENCE INSPECTION WITH ZERO OBSERVATIONSTOP STORIES
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