Independently manages multiple CMC renewals assignments for Pharma and Vaccines products
Defines and agrees on regulatory strategy
Completes data assessment to ensure CMC dossier is authored in compliance
Identifies risks associated with submission data and information packages
Escalates issues with line manager that have business impact, suggesting possible solutions
Understands regulations, guidelines, procedures and policies relating to registration and manufacturing
Identifies improvement opportunities for regulatory processes, policies and systems
Acts as mentor/trainer for new staff
Effectively communicates in a digital context, including virtual meetings and platforms
Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements

Requirements

Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields
Min. 3 years of relevant experience in regulatory affairs, pharmaceutical industry
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
Excellent written and verbal English language communication skills
Good team worker, ready to lead initiatives when needed
Excellent interpersonal skills, communication and influencing skills
Excellent time management skills to handle multiple assignments
Detail-oriented, with emphasis on accuracy, completeness and consistency
Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes
A commitment to ongoing professional development with proven ability to learn and apply new concepts
Veeva Vault knowledge would be an asset.

Benefits

Private healthcare
Additional paid days off
Life insurance
Private pension plan
Fully paid parental leave & care of family member leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategydata assessmentCMC dossier compliancerisk identificationregulatory processespharmaceutical industry knowledgedrug development environmentagile thinkinganalytical thinkingdetail-oriented

Soft Skills

communication skillsinterpersonal skillsteamworkleadershiptime managementproblem-solvingmentoringinfluencing skillsadaptabilitycommitment to professional development