Job Title

Position Overview The B.Pharm Executive will support end‑to‑end product development, from formulation assistance through research and R&D activities, while ensuring all projects adhere to current regulatory standards and internal quality systems. This role bridges the gap between laboratory innovation and market-ready products by managing technical documentation, liaising with cross‑functional teams, and maintaining strict compliance with local and international regulations. Key Responsibilities Formulation Assistance: Collaborate with R&D scientists to develop, optimize, and scale-up formulations (solid, semi-solid, liquid dosage forms) Conduct feasibility and stability studies; interpret analytical data to improve product performance Prepare and review batch records, SOPs, and protocol documents for pilot and commercial batches Research & Development Support: Perform literature reviews and competitive benchmarking to identify novel excipients and delivery technologies Assist in designing and executing laboratory experiments, managing raw material inventories, and maintaining lab equipment Analyze experimental results, compile technical reports, and present findings to the R&D team Regulatory Affairs & Compliance: Prepare and submit regulatory dossiers (CTD, DMF, FPP dossiers) to Indian authorities (DCGI, CDSCO) and maintain product files Ensure compliance with GMP, GLP, GDP and relevant guidelines (FSSAI, US FDA, EMA) throughout the product lifecycle Monitor changes in regulatory requirements; update procedures and train stakeholders on new compliance mandates Quality Systems & Documentation: Draft, review, and maintain quality documentation including validation protocols, change control forms, and deviation reports Coordinate internal audits and support external inspections; implement corrective and preventive actions (CAPA) Track key performance indicators (KPIs) for quality and regulatory timelines; generate compliance status reports Cross‑Functional Collaboration: Work closely with Procurement, Production, QC, and Marketing teams to facilitate smooth project handoffs Act as point‑of‑contact for regulatory queries, both internal and from external partners or agencies Mentor and train junior staff on formulation techniques, documentation standards, and regulatory practices Required Qualifications & Experience Bachelor’s degree in Pharmacy (B.Pharm) from an accredited institution 2–4 years of hands‑on experience in pharmaceutical formulation, R&D, or regulatory affairs Solid understanding of drug development processes, dosage form technologies, and stability testing Familiarity with Indian regulatory framework (DCGI/CDSCO) and international guidelines (ICH, US FDA, EMA) Proven ability to author and maintain technical and regulatory documents Key Skills & Competencies Technical: Formulation development, analytical techniques (HPLC, DSC, dissolution), stability protocols Regulatory: Dossier preparation (CTD format), GMP compliance, audit management Analytical & Problem‑Solving: Data interpretation, root‑cause analysis, process optimization Communication: Clear technical writing, presentation skills, ability to liaise across functions Project Management: Time management, task prioritization, milestone tracking Software: MS Office Suite, LIMS/QMS platforms, formulation modeling tools (preferred) Preferred Attributes Master’s degree in Pharmacy (M.Pharm) or equivalent Experience with herbal/nutraceutical formulations or specialized delivery systems Exposure to global regulatory submissions and multi‑site project coordination Certification in Regulatory Affairs (e.g., RAPS) or Quality Management systems (e.g., Six Sigma)