Job Title:
Trainee Regulatory Associate – Colombia
Job Summary:
A leading pharmaceutical company is seeking a Trainee Regulatory Associate to support global regulatory publishing and data management activities. This entry-level role provides hands-on experience in handling IND/NDA/MAA submissions, lifecycle management, regulatory data entry, and quality control across multiple regulatory systems in the pharmaceutical domain.
Key Responsibilities:
Provide end-to-end publishing support for initial IND/NDA/MAA applications and lifecycle maintenance globally.
Collaborate with cross-functional teams for submission planning, preparation, publishing, and quality control checks.
Develop submission-ready documents including formatting, hyperlinking, and processing MS Word and Adobe Acrobat files.
Stay updated on global regulatory agency standards and submission procedures.
Support various submission formats such as eCTD, NeES/eSub, and Paper submissions.
Troubleshoot and resolve document formatting issues with Adobe Acrobat and MS Word.
Perform quality checks ensuring zero validation errors or unacceptable warnings before final submission.
Engage in on-the-job training following the "train-the-trainer" model and provide feedback for process improvements.
Review and interpret data for regulatory system updates in line with SOPs and business processes.
Perform data entry, QC tasks, and maintain accuracy in regulatory systems like SharePoint.
Liaise with suppliers and legal teams to obtain necessary ancillaries or samples for submissions.
Support the Regulatory team during operational meetings and manage multiple project requests simultaneously.
Escalate timeline risks to appropriate contacts and ensure regulatory filing deadlines are met.
Required Skills & Qualifications:
Proficient in MS Word, MS Excel, MS Access, MS PowerPoint, and Adobe Professional.
Excellent organizational and multitasking skills.
Strong problem-solving abilities and attention to detail.
Ability to coordinate with cross-functional and global teams.
Knowledge of regulatory data systems and document management is a plus.
Good communication and interpersonal skills.
Perks & Benefits:
Entry-level position with comprehensive training and development.
Exposure to global regulatory submission processes.
Supportive work environment promoting continuous learning.
Opportunity to work with international pharmaceutical regulations and systems.
Company Description:
A globally renowned pharmaceutical company known for driving innovation in healthcare, regulatory affairs, and drug development. The organization provides opportunities for growth and professional development within a compliant and quality-focused environment.
Work Mode:
On-site – Colombia
Call to Action:
Kickstart your career in regulatory affairs with a global pharmaceutical leader. Apply now to become a Trainee Regulatory Associate and gain valuable industry experience.
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