20/08/2024
Name: Mr. Jijo Abraham Visa Status: Holding Job Seeker Visa for Germany Visa Number: 069469176 valid from 18th August 2024 until 17th February 2025 Mobile Number: +91 8408 833 145 (Bangalore, India) Dear Hiring Manager, I am a dedicated pharmaceutical professional with over nine years of experience in Regulatory Affairs and Quality Assurance. My expertise is preparing and submitting initial drug product high quality CMC dossiers, including abbreviated new drug applications (ANDA), ANDs, MAA and US new drug master files for APIs to regulatory agencies such as the USFDA, Health Canada, UK MHRA, and the European Medicines Agency. I hold a Master's in Pharmacy (Pharmaceutics) from Kerala University of Health Sciences and a Bachelor's in Pharmacy from SRM University, India. I am a Senior Executive in Regulatory Affairs (Formulation) at Micro Labs Limited, Bangalore, India. In my previous roles, I held positions as a Senior Executive – Regulatory Affairs (Formulation) at Apex Laboratories Private Limited, Regulatory Associate (API) at PAR Active Technologies Private Limited (Par Pharmaceuticals – An Endo International plc), and Senior Officer (Quality Assurance) at Glenmark Pharmaceuticals Limited. These roles exposed me to highly regulated markets in the USA, Canada, Europe and the UK. Throughout my career, I have honed my skills in regulatory affairs, particularly in preparing, reviewing, and eCTD compilation of CMC documents (ANDA, ANDs & MAA) for submission to international regulatory agencies. I am also proficient in writing chemistry, manufacturing, and control documents for drug products and substances in compliance with the eCTD format. Additionally, I have experience reviewing and approving raw material specifications, batch manufacturing records, product development reports, and change control forms. I am eager to leverage my experience and skills in a role that allows me to contribute effectively and continue my professional development. I have enclosed my CV for your consideration. If you have any questions or want to schedule an interview, please get in touch with me at the above mentioned number. I look forward to discussing how I can contribute to your team. Sincerely, Jijo Abraham
Senior Executive – Regulatory Affairs
Bangalore, Karnataka, Indien