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
Individual creation, analysis, updating, and optimization of high quality regulatory documents regarding pharmaceutical
quality (modules 1, 2 and 3) for new generic approvals (solid oral and sterile-ophthalmic products) in eCTD format.
Streamline cross-departmental collaboration to acquire ANDA and ANDs documents, ensuring seamless regulatory
compliance in the US and Canadian markets
Spearhead a regulatory team, consistently achieving punctual CMC submissions to USFDA and Health Canada
Expedite initial product registrations for solid oral dosage and ophthalmic products by meticulously scrutinizing CMC
documents for both USFDA (ANDA) and Health Canada (ANDs)
Enhance product quality and regulatory compliance through comprehensive reviews of product development reports,
USDMFs, and drug product specifications
Strengthen submission quality by analyzing ANDA and evaluating dossiers from a meticulous RTR guidance perspective
Coordinate a streamlined document collection process, efficiently resolving ANDA (IR, DRL, CRL)/ANDS (Quality Clarifax,
SDN, Screening Clarification Request, NON, NOD)-related queries from USFDA and Health Canada
Facilitate a harmonized approach to regulatory compliance by sharing essential RA requirements with product
development teams and actively reviewing critical documents (Trade Dress, IID approvals, Biowaiver strategy approval,
dissolution development report approvals, CDP, stability protocols approvals, and relevant quality document approval of
Master production documents, various risk assessment)
Optimize regulatory submission strategies by anticipating questions and challenges throughout the product development
Working closely with health authorities (eg. USFDA or Health Canada) to coordinate, communicate and manage all
regulatory interactions
Contribute to development of regulatory CMC strategy for the assigned project(s) and its proactive communication
Approving the analytical specification, methods (of in-process stages, release and stability stages) in Document
management system and the approving of change control activities in TrackWise® A Sparta System Solution