A day in the life of a Senior Regulatory Affairs Associate
Manage the preparation, compilation and submission of high quality CMC supplement/variation packages for the US, CA and EU and can also be expected to work with the Global RA Submission teams for new emerging markets including China and Japan. Secondary to this, you may also be asked to support biologic/combination drug product maintainence filings, working with Teva RA US and EU submission teams.
Critically review change controls and work closely with all departments at site to obtain the required documentation for key variations and expansion of current files to support potential new market registrations.
Manage quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.
Maintain full awareness of all regulatory activities on assigned projects ensuring that project deadlines and performance standards for these projects are established and met.
Helping to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets/KPIs are met whilst adhering to appropriate statutes, regulations and latest guidance.
Evaluate changes to regulatory documents for Teva’s Must Win and complex sterile products and formulate strategies with guidance from a supervisor.
Act as the main representative for Regulatory Affairs on cross functional project teams.
To understand and communicate complex issues to other Regulatory, Quality, Supply Chain, Product Management Medical, Pharmacovigilance, EPD and Senior Management colleagues.
Experience with regulatory documents (files, annual reports, investigations, process changes) and demonstrated ability to work effectively in a variety of IT systems (e.g. EDMS, TrackWise).
Other duties, as assigned, or as business needs require.
Who We Are Looking For
Able to manage timelines within a project team environment.
Able to work independently, without supervision, and in teams.
Able to effectively liaise with health authorities, various disciplines within Teva, and third parties.
Able to establish and maintain good working relationships.
Able to demonstrate good negotiation and management skills.
Excellent verbal and written communicator
Organised, detail oriented, able to multi-task and manage changing priorities.
Do you have?
Doctorate or Bachelor’s degree in a scientific discipline.
Regulatory Affairs experience in steriles required.
Knowledge of current regulations and guidance related to the filing, approval process and maintenance of core markets including US, EU, CA. Additional experience with ROW markets including emerging markets including China and Japan, an advantage.
Understanding of Medical Devices Regulation and Notified Body Opinions an advantage.
Good understanding of pharmaceutical drug development for complex sterile products.