Regulatory Affairs Associate/Officer - US Respiratory Generics
Harlow, United Kingdom
As a Regulatory Affairs Associate/Officer you will be responsible for:
Providing regulatory support during the development of complex respiratory combination products and, with guidance of the direct supervisor and department management, may represent Regulatory Affairs on project teams.
Attending calls with manufacturing sites, some third party, supporting the US market and will work closely with the Regulatory Affairs Director/Senior Director to provide Regulatory advice, direction and oversight. The role will involve some travel.
Managing document deliverables to ensure submission targets/KPIs are met whilst adhering to appropriate statutes, regulations and latest guidance.
Preparing and reviewing Teva’s ANDAs and related correspondence to FDA which will include Controlled Correspondence, Meeting Requests, Responses to Agency questions and other submissions as needed. You may also work on generic filings to the EU Competent Authorities.
A day in life of a Regulatory Affairs Assocaite/Officer...
Manage the preparation, compilation and submission of high quality US controlled correspondence, meeting requests, ANDA filings and responses to FDA.
Have scope to potentially manage the preparation, compilation and submission of high quality EU meeting requests, submissions and responses to Competent Authorities.
Critically review change controls and work closely with all departments at site to obtain the required documentation for upcoming submissions.
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.
Evaluate changes to regulatory documents for Teva’s products and formulate strategies with guidance from supervisor.
Act as a representative for Regulatory Affairs on cross functional project teams when required.
Interact company sites via written and phone communications.
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 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.
Organized, detail oriented, have the ability to multi-task and manage changing priorities.
Do you have...?
Bachelor’s degree in a scientific discipline.
Pharmaceutical industry experience. Regulatory Affairs experience required ideally specialising in respiratory combination products.
Strong knowledge of current regulations and guidance related to the filing, approval process and maintenance of US ANDAs.
Knowledge of current regulations and guidance related to the filing, approval process and maintenance of EU marketing authorisations an advantage.
A basic understanding of pharmaceutical drug development for respiratory products.