Sharmila Devi

Results-driven Regulatory Affairs professional with 3 years of dedicated regulatory experience and 6+ years of pharmaceutical QC background. Proficient in preparing regulatory documents, dossiers, specifications, COAs, and DMF submissions. Experienced in coordinating with cross-functional teams, managing vendor queries, and supporting FDA and HSA audits.

Recently certified in Regulatory Affairs Career Accelerator (CTD/ACTD dossier preparation, DMF compilation, ICH guidelines, and global regulatory submissions for USA, Europe, India and emerging markets).

Regulatory Affairs Executive - International Ingredients and Excipients - Chennai

(2024-03)

• Prepare regulatory documents, specifications, and Certificates of Analysis (COA) for submission to domestic and international customers.
• Manage and respond to vendor queries (international and domestic) on submitted dossiers and related regulatory documents.
• Assess change controls and vendor change notifications in a timely manner.
• Stay current with national and international regulatory legislation, guidelines, and customer practices.
• Coordinate with cross-functional teams (QA, manufacturing) to gather documentation for dossier preparation.
• Support and coordinate QMS audits, internal audits, and complaint management.
• Meet vendor requirements by submitting appropriate supporting documents.

Senior Quality Control Analyst - GlaxoSmithKline Pharmaceuticals Ltd. - Singapore

(2012-01 - 2015-12)

• Performed analysis of raw materials, intermediates, APIs, and in-process samples per SOPs.
• Authored and issued Standard Operating Procedures (SOPs).
• Conducted 6S-checklist audits; supported CAG, FDA, and HSA audit preparation through document verification and calibration file review; directly interfaced with auditors.
• Managed batch release, sample and data management, and data validation using LIMS and SAP.
• Led laboratory investigations and root cause analyses for OOS and OOT results.
• Performed HPLC method validation using Empower 2 software; chiral analysis and organic volatile impurities testing by GC.
• Conducted stability sample packing, storage, and periodic analysis within stipulated timelines.
• Performed specific rotation, IR, UV, particle size, Karl Fischer moisture, TLC, heavy metals, and sulphated ash testing for APIs and intermediates.
• Calibrated and troubleshot analytical instruments; followed GLP, GMP, and ICH guidelines.

Chemist - SGS Testing & Control Services Pte Ltd - Singapore

(2011-07 - 2012-01)

• Supported analytical method transfer for new drug products.
• Performed analysis of capsules, creams, and tablets per approved procedures — including friability, dissolution, conductometry, TOC, UV, BOD, COD, HPLC, and GC-MS.
• Assisted with swab sample analysis and TOC testing for ad hoc samples.

Laboratory Analyst (Internship) - Davos Life Science Pte Ltd - Singapore

(2009-12 - 2010-06)

• Analysed Vitamin-E concentration extracted from palm oil using HPLC and titration.
• Maintained chemical storage, labelling, and experimental data records; assisted senior chemists.

Lecturer - PSN Engineering College - Tirunelveli

(2007-07 - 2008-11)

• Taught Organic, Inorganic, Environmental, and Physical Chemistry to engineering students; conducted lab sessions and supervised university examinations.

Instructor - New Prince Shri Bhavani Vidhyashram CBSE School - Chennai

(2018-04 - 2019-08)

• Taught and conducted laboratory activities; tracked student progress and mentored student teachers.

Diploma - Chemical Process Technology (Pharmaceuticals) - Institute of Technical Education (2010 - 2010)

M.Sc.

• Chemistry - The American College (2007 - 2007)

B.Sc.

• Chemistry (University Rank Holder) - Sri Sarada College for Women (2005 - 2005)

Bachelor - Education - Vadaranyam college of education (2021 - 2021)