Compliance Engineer leading vehicle emissions certification and collaborating with cross - functional teams at General Motors. Delivering presentations and project management with engineering methods.
About the role
- Senior Regulatory Specialist managing CMC renewals for Pharma and Vaccines. Collaborating across global teams to ensure compliance with regulatory requirements in pharmaceutical industry.
Responsibilities
- 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
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