Career Category

Job Description

Job Summary:

• Perform a variety of administrative activities to support team members within local Regulatory Affairs / Safety

Key Activities:

• Technical support to regulatory/safety for different projects, incl. CTA preparation, regulatory projects, safety related tasks, translations. Perform physical submission packages to BDA, EC, receive, deliver and disseminate authorities’ correspondence/approvals. Validate fees with health authorities’ account departments
• Maintenance of regulatory registers; perform archiving activities
• Prepare and process routine forms, documents and correspondence
• Answer phones, making proper referral or handling as appropriate
• Disseminates information to appropriate parties in a timely manner; monitors and/or follows-up on appropriate items
• As appropriate, open, read, sort, prioritize and distribute incoming mail; ensure outgoing mail and packages are prepared properly and scheduled for delivery
• Plan and organize work to ensure accurate and logical organization of files, documents and records; ensure effective control of forms; control confidentiality of files as necessary
• Copy/scan documents
• Monitor office supply inventory and order as necessary in coordination with receptionist
• Manage multiple and/or complex calendars
• Coordinate domestic/international travel arrangements within local Regulatory Affairs department
• Utilize basic forms (i.e. check request, expense reports)
• Coordinate onsite/offsite meetings under minimal supervision ( within Regulatory Affairs/Safety function)
  Interact with outside vendors
• Type presentations
• Organize and expedite workflow to comply with deadlines and priorities
• Prepare and process forms, documents and correspondence; anticipates, revises and sends correspondence (liaise with receptionist for courier services)
• Compile data and information to be sent to various external groups
• May take basic meeting minutes/action items; needs to ask others to review or clarify terms
• Project tracking: (i.e. budget, database, timelines)
• Serve as a point of contact for information regarding areas of responsibility
• Interact effectively with various levels of management
• Coordination of local Regulatory Affairs/Safety function related activities with other ACs
• Assist with special projects as requested by manager

Minimum Requirements

• Excellent phone etiquette
• Excellent written and verbal communication skills
• Excellent written and spoken English
• Strong organizational and interpersonal skills
• Able to manage multiple tasks, prioritize and meet deadlines
• Able to resolve problems with limited supervision
• Knowledge of relevant corporate and government laws and regulations impacting job function
• Microsoft Suite: Word, Excel, PowerPoint, Outlook
• Bachelor’s degree or 2 years of directly related experience