Manager, Legal

2 weeks ago

Parsippany, New Jersey, United States Teva Pharmaceutical Industries Full time

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.

Job DescriptionThe Manager is responsible for the generation, revision, submission, supervision, & critical review & approval of pre & post approval NDA 505(b)(2) labeling.

In addition, assists, when needed, in the review of Gx labeling documents filed under an ANDA while adhereing to federal regulations & internal processes & meeting deadlines driven by company goals.

The Manager will also be responsible for their own assignments, when needed, working closely with US Managers surrounding the review & approval of all labeling documents established.

Will oversee any/all team databases & trackers & will accurately update them when changes are required.

The candidate must possess a firm knowledge of FDA US labeling regulations surrounding NDAs 505(b)(2) & ANDAs, as well as FDA guidances & be considered a SME in all facets of US labeling including but not limited to SPL , PADERs, & annual report compilation in order to provide direction to direct reports for projects assigned.


Responsibilites:

Hands on leader in regard to daily work load of labeling for NDA 505(b)(2) applications; SME in the development, review, & electronic compilation of labeling documents to align with the RLD, FDA solicited safety changes, company processes, & submission requirements for assigned NDA 505(b)(2)s or ANDAs.

Responsible for assuring that projects are assigned to direct reports and/or external team members in order to meet departmental goals, FDA timelines, & to all company objectives are met.

Communicate, plan, prioritize, & perform training in order to ensure labeling documents prepared align with company goals, submission requirements, legal, & regulatory requirements.

Perform in depth quality reviews of labeling & submission documents prior to final disposition to the agency.

Maintain the labeling tracker in order to ensure all assigned projects remain on track by direct reports & re-prioritize, when needed.

Work with Regulatory Operations to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling.
Maintain a metric of all team projects for reporting purposes.
Experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities is preferred.
Performs all other job related duties as required by management.


QualificationsMsc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience Total years of experience required for the role: 6 to 7 years of US labeling experience, with a focus on NDA 505(b)(2) applications + 1 year supervisory experienceRelevant years of experience: 6 to 7 years Pharmaceutical industry experience required, specifically in Regulatory Affairs & US NDA 505(b)(2) / ANDABe able to multi-task in a fast paced work environment Have exemplary oral and written communication skillsBe organized with a keen attention to detailHave the ability to work independently as well as in a team environment Demonstrate a thorough understanding of FDA US regulations and guidances related to US NDA/ANDA labeling Have knowledge of FDA eCTD submission Demonstrates the ability to establish and maintain good working relationships within company and with external contacts.

Proficient knowledge of SPL development and FDA drug listing requirementsPC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
Adobe Acrobat Professional

Familiarity with TVT and Intagras SPL portal preferredFunctionRegulatory AffairsSub FunctionMedical Regulatory AffairsReports ToIn process of validationAlready Working @TEVA?By doing so, your application will be treated with priority.

Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.

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