Sr Specialist - Regulatory Affairs

Overview

This role provides regulatory support for on-market products, covering change assessment, variation planning, submission documentation, and local submission requirements.

What you'll do

• Review and provide regulatory impact assessments for changes
• Support global submission deliverables for product variation submissions
• Work with other parts of the regulatory organization to achieve desired results
• Execute global plans and regulatory submission deliverables for sustaining variations
• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
• Ensure identified standards and content requirements are met for regulatory submissions
• Actively support timely query responses
• Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities align with business requirements
• Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s)
• Maintain regulatory files in a format consistent with requirements
• Track status, quality/compliance and progress of regulatory documentation
• Review, edit and proofread regulatory documentation

What you'll need

• Master's Degree or country equivalent in related scientific discipline
• 7+ years of regulatory experience in RA or related healthcare environment
• Experience in Regulatory Information Management (RIM) systems, including managing regulatory data, submissions, registrations, and maintaining data quality and compliance
• Experience in CMC regulatory authoring, including preparation and review of CTD Module 3 documentation and supporting global regulatory submissions throughout the product lifecycle
• Experience operating in a regulated environment
• Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
• Ability to exercise independent judgement
• Scientific knowledge and ability to discuss technical matters with cross-functional team members
• Knowledge of regulations and ability to communicate and apply them
• Ability to identify compliance risks and escalate when necessary
• Excellent verbal and written English communication skills, suitable for multi-location working relationships
• Demonstrated teamwork and collaboration skills
• Aptitude for attention to detail

Nice to have

• Higher degree/PhD