Manager, Regulatory Affairs

Manager, Regulatory Affairs

Teva

Waterford, Ireland

We are looking for a Manager to join the Regulatory Affairs team, who will be responsible for providing regulatory support during the development of complex respiratory combination products and the supervision, preparation, and critical review for Teva’s Must Win ANDA filings to the Agency (also including Controlled Correspondence, Meeting Requests, Responses to Agency question and other submissions as needed).

The Manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to their supervisor. The incumbent, with minimal guidance, evaluates key documentation and helps to resolve issues for Teva’s Must Win and complex products, The Manager will represent Regulatory Affairs on project teams and serves as team leader for projects. The Manager will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets/KPIs are met while adhering to appropriate statues, regulations and guidance’s

A day in the life of our Manager, Regulatory Affairs

  • The Manager will be help to take the lead on intra/inter departmental/cross-functional initiatives and continuous improvement initiatives.
  • Manage the preparation, compilation and submission of high quality: controlled correspondence, meeting requests, ANDA filings and responses.
  • Critically review change controls and work closely with all departments at site to obtain the required documentation for upcoming submissions.
  • Manages quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met..
  • Evaluates changes to regulatory documents for Teva’s Must Win and complex products and formulate strategies with guidance from supervisor.
  • Acts as main representative for Regulatory Affairs on cross functional project teams.
  • Interacts with FDA and all of the company sites via written and phone communications.
  • The incumbent will attend calls with 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 minimal travel

Who we are looking for

Are you….

  • Excellent with communicating both verbally and via written communications?
  • A problem solver who is able to make critical decisions and has an analytical, strategic and scientific thinking style?

Do you have….

  • A degree in a scientific or healthcare discipline or equivalent experience?
  • Multiple years’ Regulatory Affairs experience required coupled with at demonstrable experience in respiratory combination products
  • Strong knowledge of current regulations and guidances related to the filing, approval process, and maintenance of ANDAs.
  • Ability to manage timelines within a project team environment.
  • Ability to work independently, without supervision, and in teams.
  • Ability to effectively liaise with FDA, various disciplines within Teva, and third parties.
  • Ability to establish and maintain good working relationships.
  • Demonstrates good negotiation and management skills.
  • Excellent verbal and written communication skills.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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