Job Title : Associate - Regulatory Affairs CMC (India) Dept. : R&D / RA Line Manager Job Title : Lead Regulatory Affairs CMC (India) Job Purpose : The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products. Key Responsibilities : - Responsible for CMC regulatory matters relating to registrations and/or maintenance of business activities (including variations and renewals) for assigned product portfolio especially - Oral health products such as toothpastes, mouthwashes, gels, denture tablets etc registered as cosmetics, medical devices, drugs and / or quasi drugs across diverse regions especially EU, US, CEE and Asia Paciifc regions - Preparation of CMC sections of new registration files, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions and other documents as needed, with support from supervisor. - Interacts with colleagues in other global functions (e.g. Tech Excellence and Supply Chain) and Regulatory Affairs sub-functions to deliver high quality CMC dossiers, documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance. - Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls. - Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls. Knowledge/ Education / Previous Experience Required : Educational Background : 1. Minimum Level of Education - Degree in a pharmaceutical or life science or equivalent regulatory experience Area of Specialisation - Science, Life Sciences - Medicinal/Medical Device/Cosmetic Regulation Why is this Level of Education Required? Ensures basic level of scientific/regulatory understanding 2. Preferred Level of Education Degree in a pharmaceutical or life science or equivalent Area of Specialisation - Life Sciences B. Job-Related Experience : Minimum Level of Job-Related Experience required 1-5 years- regulatory affairs experience including CMC and ideally OTC experience (incl. devices, cosmetics, foods/supplements depending on category)

Hyderabad

GlaxoSmithKline - Associate - Regulatory Affairs - Oral Health 

GlaxoSmithKline - Associate - Regulatory Affairs - Oral Health  ,Job Description for GlaxoSmithKline - Associate - Regulatory Affairs - Oral Health  in GSK in  Hyderabad for (1-5) years of experience. Apply Now!

Job Description for GlaxoSmithKline - Associate - Regulatory Affairs - Oral Health  in GSK in  Hyderabad for (1-5) years of experience. Apply Now!