Job Description

• Support regulatory activities and license maintenance of assigned product portfolios.

• Support IDMP and XeVMPD data readiness.

• Execute CMC package building and approval in client system.

• Support labeling and annual reports submission.

• Coordinate with the local regulatory affiliates to collect the necessary information and raise request for required certificates.

• Coordinate with client vendor for legalization by ensuring all relevant data is provided including payment.

• Respond to questions, if any and ensure the certificate is issued and legalized within the agreed timeline.

• Track all submission requests simultaneously to ensure submission timeline is adhered.

• Any delay in the process to be escalated to client stakeholders.

• Drug listing activities for the approved products and other product licensing support activities to maintain compliance.

• Actively participate in cross-functional teams as appropriate.

• Development and maintenance of documented procedures and guidelines as necessary.

• Compliance with client s SOPs/Work Instructions and other standards, as applicable.

• Ensure quality is maintained in all data entry and other regulatory operations activities.

Requirements

• Qualification: Bachelors Degree desirable.

Years of Experience

• Should have 0-2 years of relevant experience.

Skills

• Demonstrated ability to work within a demanding environment with a strong focus on quality and timelines.

• Fundamental knowledge of CMC and other regulatory submissions.

• Proven technical aptitude and ability to quickly learn and apply new software, regulations, and quality standards.

• Can demonstrate proactiveness and capabilities to manage tasks independently. Has good collaborative skills.

• Advanced Microsoft Office Suite skills.

• Should have excellent verbal & written English communication skills.

Company Profile:

Salary: Not disclosed

Industry: BPO / ITES

Functional Area:

Role Category:

Employment Type:

Keyskills