Job Title: Regulatory Associate
Location: Bogota, Colombia
Department: Regulatory Affairs
Reports To: Associate
Employment Type: Full-Time
Educational Qualification:
Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry, or related life sciences field
Support regulatory data management and compliance activities by reviewing, interpreting, and managing data in alignment with client SOPs and business processes, ensuring quality and regulatory compliance.
Regulatory Data Management:
Review and interpret data to determine system/tools requirements in line with client SOPs and business processes.
Perform data entry and quality control tasks associated with regulatory systems.
Review audit reports and resolve errors to maintain data integrity.
Identify issues and provide input for solutions.
Perform retrospective remediation tasks as needed.
Compliance & Quality:
Adhere to quality control procedures and standards to ensure regulatory compliance.
Act as Regulatory Data Subject Matter Expert (SME) for supported regions.
Support audit activities within the regulatory data/system scope.
Produce country/regional reports as required.
Team Support & Collaboration:
Support global/local team members with data management workload when necessary.
Work autonomously and collaboratively in a busy environment.
Minimum 1–2 years of pharmaceutical industry experience.
Experience in a highly regulated environment.
Strong communication skills in English (intermediate to advanced, written and spoken).
Ability to work with accuracy, attention to detail, and problem-solving skills.
Proficiency in MS Office and other relevant software packages.
Customer service orientation and quality-focused mindset.
Regulatory strategy experience.
Project management and coordination skills.
Technical aptitude and ability to quickly learn new software, regulations, and quality standards.
Self-motivated, quick learner, and able to multi-task.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
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Siliguri |Illinois :
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