Role & responsibilities Analytical Method Development Analytical Method Validation Analytical Method Transfer Data Compilation , preparation of Report of all ARD Activities. Drug Formulation : Oral Solid Dosages, Liquid Orals, Injections , Semi-Solids Preferred candidate profile Minimum of BS in Chemistry / B . Pharm or related field in the physical or life sciences required Knowledge of and experience with the Analytical Method Development and Validation Required. Experience working with/for CDMOs preferred Must be outgoing, energetic, self-motivated. Enjoy interacting with people, scientific discussions, and strategic thinking and planning
Role & responsibilities Analytical Method Development Stability & Routine Analysis IVRT Instrument handling. Analytical Method Transfer Data Compilation, preparation of Report of all ARD Activities. Drug Formulation : Oral Solid Dosages, Liquid Orals, Injections , Semi-Solids Preferred candidate profile Minimum of BS in Chemistry / B . Pharm or related field in the physical or life sciences required Knowledge of and experience with the Analytical Method Development and Validation Required. Experience working with/for CDMOs preferred Must be outgoing, energetic, self-motivated. Enjoy interacting with people, scientific discussions, and strategic thinking and planning
Role & responsibilities Routine Stability Analysis ( RS / Assay/Dissolution ) Drug Formulation : Semi-Solid, Oral Solid , Liquid , Injections. GDP and GLP Documentation Instrument Calibration Preferred candidate profile Minimum of BS in Chemistry / B Pharm Must be outgoing, energetic, self-motivated, and an organized team player Enjoy interacting with people, scientific discussions, and strategic thinking and planning Should have knowledge and experience of operating analytical instruments like HPLC, Dissolution, UV, Karl. Fisher etc..
Role & responsibilities Review of Analytical Documents ( Method Development and Validation )and Data Review of Method Development and Method transfer activities Drug Formulations : Oral Solid Dosages, Liquid Orals, Semi-Solid and Injections. Maintaining GDP and GLP documentation as per ICH guidelines w.r.t to product development method development, validation. Finalization of Method Analysis, Specifications and Justification of Specifications. Preferred candidate profile Minimum of BSc in Chemistry / B Pharm or related field in life sciences required. Experience with CGMP / CDMO sites. Knowledge of and experience with the drug development process preferred Experience with formulation development/drug product manufacturing service offerings preferred Must possess excellent presentation, written, and verbal communications skills Experience working for CDMOs preferred Must be outgoing, energetic, self-motivated, and an organized team player and flexible in working. Enjoy interacting with people, scientific discussions, and strategic thinking and planning Must speak fluent English Minimum experience of 10 years for review of documents as required by EU guidelines, candidate should have worked for EU markets. Through knowledge of Analytical Chemistry , BP, USP and other ICH guidelines.
Role & responsibilities Role Overview: The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory submissions (CTD/eCTD) in line with EU/UK/and other global regulatory requirements. The role requires close coordination with cross-functional teams (Formulation, Analytical, Quality, Production, and Packaging) to ensure timely and compliant dossier submissions. Responsibilities : Compile, review, and manage dossiers (Modules 1-5) for regulatory submissions via MRP, DCP, and national procedures according to EMA and ICH guidelines in eCTD format. Ensuring and responsible for CMC activities, pre submission dossier preparation, post approval variation activities and life cycle management of the dossier. Prepare, review, and update Module 3 (Quality/CMC) sections for new submissions Responsible for reviewing and approvals of documentation for tech transfers projects from R&D as well as finished product manufactures, API manufactures, raw material manufactures Evaluate and perform scientific literature searches for reference products, market analysis, bioequivalence, and biowaiver strategies. Support review and compilation of relevant parts of Module 2 (Quality Overall Summary) and relevant cross-references in Modules 1 and 2. Ensure documents and data comply with EMA, MHRA, FDA, and ICH guidelines. Liaise with internal teams and CMOs for timely receipt of technical data and reports. Review technical reports such as process validation, analytical validation, and stability data for regulatory adequacy. Manage project coordination and multitasking across departments Compile and respond to deficiency letters during assessment phases within timeframe including post approval variations. Ensure proper documentation and adherence to Good Laboratory Practices (GLP), supporting audits as required. Preferred candidate profile B.Pharm/ M. Pharm / M.Sc. in Pharmaceutical Sciences or related field. 8-10 years of hands-on experience in Regulatory Affairs CMC / Quality documentation specifically in UK and Europe Working knowledge of CTD/eCTD format and global submission requirements. Proficiency in MS Office and document management tools. Excellent communication, coordination, and time management skills and skills to work with internal team.