1+ months

Manager Regulatory Affairs

Parsippany, NJ 07054
Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

The Regulatory Affairs Manager is responsible for:

  • Providing regulatory support during the development of complex respiratory combination products and the supervision, preparation, and critical review for Tevas 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 his/her supervisor.
  • The incumbent, with minimal guidance, evaluates key documentation and helps to resolve issues for Tevas Must Win and complex products,.
  •  He/she represents 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 guidances. 
  • 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 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.
 Coaches, mentors and provides guidance to the regulatory associates as necessary.
 Evaluates changes to regulatory documents for Tevas 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.
 Other duties, as assigned, or as business needs require.

 

Requirements:
 PharmD/BS degree in a scientific discipline.
 Minimum 5+ years Regulatory Affairs experience required coupled with at least 3 years experience in respiratory combination products.
 Previous Managerial experience preferred
 Exhibits strong knowledge of current regulations and guidances related to the filing, approval process, and maintenance of ANDAs.
 Demonstrates a basic understanding of pharmaceutical drug development for respiratory products.
 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. 
 Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

The role will involve some travel to Europe

Categories

Posted: 2020-05-21 Expires: 2020-08-09

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Manager Regulatory Affairs

Teva Pharmaceuticals
Parsippany, NJ 07054

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