Results-driven RA Specialist at Thermo Fisher Scientific with extensive experience in regulatory affairs, specializing in eCTD document preparation and submission while ensuring compliance with global regulatory standards. Holds a Master's in Physical Sciences (Medical Chemistry) and a Bachelor's in Technological Sciences (Industrial Biotechnology). Skilled in authoring and reviewing regulatory documents, proficient in managing project timelines, and collaborating with regulatory bodies. Proven track record of leading successful team initiatives, demonstrating exceptional communication skills, and innovative problem-solving abilities. Committed to achieving excellence in regulatory affairs through continuous learning and dedication to delivering positive outcomes.
Ensured compliance with U.S. FDA and Health Canada regulatory requirements on ancillary materials.
Preparation of DMFs in eCTD format, and other CMC regulatory packages.
Processed requests from competent authority efficiently. ISO9001, ISO13485
Coordinated EMEA veterinary medicine registration efforts. eCTD, DMFs, etc.