Job Purpose

This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.

Key Responsibilities

· Review and provide regulatory impact assessments for changes

· Support global submission deliverables for product variation submissions

· Responsible for working 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

· Timely, actively support query responses

· Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment 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

· Tracking of status, quality/compliance and progress of regulatory documentation

· Review, edit and proofread regulatory documentation

Key skills and competencies

· Experience operating in a regulated environment

· Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines

· 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

· 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 See Less