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: Bachelor’s 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.
• Acts decisively and seizes accountability.

• Interested candidates can share their updated CVs to milanashree.r@clinchoice.com