Senior Manager, Regulatory Affairs - Remote

Overview

The Senior Manager, Regulatory Affairs will play a crucial role in supporting regulatory submissions and compliance in the pharmaceutical industry, ensuring that products meet local regulations.

In Short

• Support change applications and submission strategies.
• Compile dossiers and prepare necessary documents.
• Review documentation for compliance with regulations.
• Manage local regulatory affairs requirements.
• Communicate with local Health Authorities on behalf of clients.
• Assist in issue management and lifecycle management activities.
• Review promotional materials for compliance.
• Collaborate with cross-functional teams.
• Maintain databases for regulatory tracking.
• Contribute to periodic safety reports.

Requirements

• Life Science Degree (Pharmacy degree preferred).
• 5-10 years of experience in Regulatory Affairs.
• Knowledge of Health Authority requirements.
• Experience in lifecycle management of medicinal products.
• Strong communication skills.
• Ability to manage artwork and supply strategies.
• Experience with regulatory submissions.
• Proficiency in cross-functional communication.

Benefits

• Competitive salary and benefits.
• Opportunities for professional development.
• Supportive work environment.
• Health and wellness programs.
• Work-life balance initiatives.