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Manager Regulatory Affairs

3 months ago

Parsippany NJ, United States Teva Pharmaceutical Industries Full time

Who are we?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 growthJob DescriptionThe Manager is responsible for the generation, revision, submission, supervision, & critical review & approval of pre & post approval NDA  505(b)(2) labeling. Leads Generic Product Working Group (gPWG) meetings (per SOP) with appropriate stakeholders when establishing/revising  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. Finally, candidate will be responsible for assuring that all required FDA reporting obligations are met in accordance with business objectives & regulations & provide guidance & leadership to direct reports with regard to best practices in the labeling arena.Responsibilites: Hands on leader in regard to daily work load of labeling for NDA 505(b)(2) applications; in addition to managerial responsibilities, this position will have independent work assignments.    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.
    Work collaboratively to implement labeling/artwork changes with sites & all releavant departments.
    Work closely with external departments/sites including, but not limited to, PV, IP, Marketing, CMC & Device team(s) to align with product/device strategy.
    Attend meetings.
    Train & develop respective team members, as well as new labeling personnel.
    Write, revise, and/or train on SOPs/WIs, as appropriate.
    Maintain a metric of all team projects for reporting purposes.
    Maintain knowledge of US regulations, guidelines, & SOPs applicable to US labeling.
    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?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: 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.Teva’s Equal Employment Opportunity CommitmentWe are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. 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. As required by applicable law, however, Teva will consider requests for reasonable accommodations