Regulatory affairs specialist clinical trials & gm

As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and execution of clinical trials and the regulatory approval of new drugs. You will collaborate closely with clinical operations and quality assurance to ensure compliance with global regulatory requirements, including Good Manufacturing Practices (GMP), and prepare regulatory submissions for authorities such as the FDA, EMA, and Health Canada.

Key Responsibilities:
Prepare and submit clinical trial regulatory documents to health authorities, including the FDA, EMA, Health Canada, INVIMA and Institutional review boards (IRBS) and others.
Ensure compliance with global regulatory requirements for clinical trials, including Good Manufacturing Practices (GMP) and Good Clinical Practice (GCP) standards.
Assist in the development and review of Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA).
Monitor regulatory changes and updates from global health authorities and communicate these changes to internal teams.
Support clinical operations by providing regulatory guidance throughout the study lifecycle.
Maintain accurate and up-to-date regulatory files and databases to ensure compliance with record-keeping standards.
Contribute to quality assurance audits and inspections of clinical trials and manufacturing processes.

Qualifications:
Bachelor’s or master’s degree in a life sciences-related field (e.g., PharmaD, Pharmacology, Biochemistry, or related discipline).
1-3 years of experience in regulatory affairs, particularly in clinical trials and GMP environments.
Strong knowledge of global regulatory guidelines, including FDA, EMA, and Health Canada requirements for clinical trials.
Familiarity with GMP and GCP standards.
Excellent organizational skills and attention to detail in handling regulatory documentation.
Ability to manage multiple projects simultaneously and meet strict deadlines.
Strong written and verbal communication skills in English.
Preferred Qualifications:
Experience preparing and submitting regulatory documents to health authorities.
Knowledge of investigational product development processes and clinical trial regulations.

About IGC Pharma SAS:
IGC Pharma SAS, is based in Bogota and is a subsidiary of an NYSE-listed U.S. start-up development-stage pharmaceutical company that focuses on preventing and managing Alzheimer’s and other CNS diseases. We also develop, manufacture, and over-the-counter market products for women’s health. We are an exciting, young, diverse workplace with excellent benefits, including travel to the U.S., training, competitive salary, bachata classes, hiking trips, Mysore coffee, and oolong tea. We practice a purpose-driven adhocracy culture. This position is based in Bogota.

Are you this person?
Are you a highly talented, collaborative, intelligent, compassionate, committed, well-traveled, self-driven individual with leadership qualities, a passion for working in health care, a calling to help make lives better and driven by numbers?

Profesional

Universitaria

Derecho Abogado

Ingeniería química

Medicina

1 año de experiencia

1 Vacante