Regulatory Affairs Specialist I

Job Description:

Position Objectives and Responsibilities

• Global – Responsible for the overall product strategy, global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management.
• Regional and/or Local - Responsible for pharmaceutical, consumer and medical device regulations in Regional and Local markets. The team partners closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance.
• Provide support to internal/external business stakeholders
• Actively participate in team activities

Skills

• Ability to understand scientific and regulatory requirements
• Working knowledge of dossier section authoring and compilation for submissions
• Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Thorough understanding of regulatory processes and information systems
• Command of English language (verbal and written)
• Excellent interpersonal skills; ability to work and contribute to a team environment
• Self-motivated and capable of working with supervision and guidance
• Demonstrated ability in analytical reasoning and critical thinking skills
• Ability to handle multiple tasks and meet deadlines
• Excellent organizational and communication skills; both oral and written
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Activities will be conducted under supervision

Requirements

Minimum Associate degree, Bachelor degree preferred or equivalent related training.

0-1 year of Regulatory Affairs experience or related experience in a regulated environment.

Knowledge in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project).

This position may be available in the following location(s): US - Remote