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Regulatory Affairs Manager - US Respiratory Generics

Date: Oct 20, 2021

Location: Harlow, GB, CM20 2FB

Company: Teva Pharmaceuticals

Who we are

 

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.

We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

 

As a Regulatory Affairs Manager you 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 primarily to the US FDA (also including Controlled Correspondence, Meeting Requests, Responses to Agency question and other submissions as needed). Secondary to this, you may also work on generic filings to the EU Competent Authorities.
  • Evaluating complex regulatory issues and providing accurate and timely recommendations and alternatives, as needed, to your supervisor. With minimal guidance, you will evaluate key documentation and help to resolve issues for Teva’s Must Win and complex products.
  • Representing Regulatory Affairs on project teams and serving as RA lead for assigned projects.
  • 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.
  • Attending calls with sites, some third party, supporting primarily 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.
  • Taking the lead on intra/inter departmental/cross-functional initiatives and continuous improvement initiatives.

 

A day in life of a Regulatory Affairs Manager...

 

  • 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.
  • Coach, mentor and provides guidance to regulatory associates as necessary with the potential to line manage in future.
  • Evaluate changes to regulatory documents for Teva’s Must Win and complex products and formulate strategies with guidance from a supervisor.
  • Act as the main representative for Regulatory Affairs on cross functional project teams.
  • Interact with FDA and all of the company sites via written and phone communications.
  • Other duties, as assigned, or as business needs require.

Who we are looking for

 

Are you...?

  • 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
  • Organized, 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 required coupled with experience in respiratory combination products.
  • Previous Managerial experience preferred.
  • 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.
  • Knowledge of the EU Medical Devices Regulation and Notified Body Opinions an advantage.
  • Good understanding of pharmaceutical drug development for respiratory products.

What do we offer you?

 

  • Permanent and full-time contract
  • Company bonus scheme
  • 25 days annual leave plus Bank Holidays
  • Flexible benefits including health insurance, gymflex and cycle to work scheme
  • Programme of Wellbeing initiatives including on-site Creative Rooms, Employee Assistance Programme, Wellbeing Champions

Function

Regulatory Affairs

Reports To

Director Regulatory Affairs

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.