A regulatory affairs professional with more than 12 years of work experience and with a strong academic background in Pharmaceuticals. Have hands on experience in preparation, review, submission of pre approval and post approval regulatory documents (parenteral and oral solid dosage forms). I am passionate about my profession as I get involved in process of bringing drugs to market available for public use.The following are my key strengths:1) Regulatory life cycle management which includes pre approval as well as post approval submissions to health authorities like US, EU, Other Advanced Markets and Emerging Markets2) eCTD compilation and publishing3) Expertise with Veeva, LIQUENT, ETQ Reliance, pharmaREADY, LORENZ eValidator, Harmony eLabel and SPL Xforms4) Regulatory compliance5) Corporate communication with clients as well as to health authorities representing company's internal procedures/processes6) Assessment of critical change control reportable to regulatory authority7) SOPs and Regulatory submissions database management8) Strategic regulatory consulting for timely product launches9) Project management skills for timely submission of dossiers10) Supporting other cross functional teams (Business Development, QA, Operations, etc.) for CMC, Regulatory and Quality related inquires