Regulatory Submissions Specialist — Life Sciences

MSC Quintiles Mexico S. de R.L. de C.V.; Bogotá; On-site; COP 90,000,000 - 130,000,000; Full time

Job summary

IQVIA is seeking a Regulatory Affairs professional to support clinical trial filings and marketing submissions. You will contribute to project teams and prepare documentation under supervision, communicating clearly with clients and colleagues.

Responsibilities include tracking timelines, delivering presentations, and assisting with trainings. A Lifescience degree and 2–3 years of regulatory experience are preferred, with strong English skills.

Qualifications

• Bachelor's Degree in Lifescience or related discipline (concluded).
• Master's Degree in Lifescience or related discipline is a plus.
• At least 2-3 years relevant experience in Regulatory Affairs, Publishing and Submission activities.
• Fluent English (writing, speaking, reading).
• Solid understanding of R&D processes (Chemistry, Manufacturing & Controls).
• Strong communication and organization skills.
• Ability to work with clients and coworkers effectively.
• Proficient with Microsoft Office and publishing tools; shows initiative.
• Self-motivated and enthusiastic; able to handle multiple projects.
• Ability to follow SOPs and contribute to process improvements.
• Decision-making on discrete tasks under supervision.
• Advanced knowledge within a discipline based on experience/education.
• Implements enhancements in systems/processes to boost effectiveness.
• Problems faced are generally not highly complex.
• Applicable certifications/licenses as required by regulations.

Responsibilities

• Acts as Regulatory Team Member on small projects under guidance.
• Identifies needs, tracks timelines, and manages workload with seniors.
• Prepares and reviews regulatory documentation in area of expertise.
• Participates in project teams with internal/external clients.
• Prepares slides/backgrounds for small business meetings and presents when needed.
• May deliver trainings as appropriate.
• Performs other tasks delegated by Regulatory management.
• Makes minor system/process changes to resolve common problems.

Skills

Fluent English

Interpersonal communication

Project coordination

Independent thinking

Education

Bachelor's Degree in Lifescience or related discipline

Master's Degree in Lifescience or related discipline

Tools

Microsoft Office

Publishing tools

Clinical PDF Publishing

Job description

IQVIA is seeking a Regulatory Affairs professional to support clinical trial filings and marketing submissions. You will contribute to project teams and prepare documentation under supervision, communicating clearly with clients and colleagues.

Responsibilities include tracking timelines, delivering presentations, and assisting with trainings. A Lifescience degree and 2–3 years of regulatory experience are preferred, with strong English skills.