Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level regulatory affairs position. Ready to help team achieve company goals.
· Actively involved in OOAC(OUT OF ACTION), OOAL(OUT OF ALERT) along with teammates related to environmental monitoring excursion investigations.
· Collection of supporting documents required for investigation.
· Adhered to SOP’S (standard operating procedures) and good documentation practices.
· Coordinating with production team, QA team and other cross functional teams for documents.
Excellent coordination and team management skills with flexible approach to work
Good verbal and written communication skills with active listening ability, fluency in English
Basic knowledge in ICH GCP guidelines, SOP, adverse events, adverse drug reactions, medical terminology and regulatory bodies [FDA, EMA] and clinical research, preclinical, data integrity
Well organized with time management skills
Adaptable and flexible, quick learner, problem solving skills, attention to detail, analytical thinking,good interpersonal skills
Proficient in MSWord and power point
Multitasking