Manager Regulatory Affairs

3 weeks ago

Parsippany, 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

  • Regulatory Affairs Manager

    21 hours ago

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

    Job DescriptionJob Summary:The Regulatory Affairs Manager will be responsible for the generation, revision, submission, supervision, and critical review and approval of pre- and post-approval NDA 505(b)(2) labeling. This role will lead Generic Product Working Group (gPWG) meetings with appropriate stakeholders when establishing or revising labeling.Key...

  • 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...

  • Regulatory Affairs Staff Specialist

    1 week ago

    PARSIPPANY, United States Diagnostica Stago, Inc. Full time

    Diagnostica Stago, Inc., (DSI) is an industry leader in the science of hemostasis and thrombosis. Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services. ...

  • Medical Affairs Manager

    4 weeks ago

    Parsippany, United States Zoetis Full time

    Zoetis Petcare Medical Affairs is composed of a group of talented therapeutic medical experts who partner with marketing brand managers to develop strategies for the brands they support, lead medical strategies, data generation plans, and educational projects, and are the medical experts in reviewing and creating educational and advertising/promotional...

  • head of global kol management and academic affairs, global medical affairs

    3 weeks ago

    Parsippany, New Jersey, United States Zoetis Full time

    Role DescriptionThe Head of Global KOL (Key Opinion Leader) Management and Academic Affairs will play a pivotal role in shaping and executing our engagement strategy with key opinion leaders and academic institutions across geographies and all species. This position requires a dynamic leader with a deep understanding of the veterinary pharmaceutical...

  • Veterinary Medical Affairs Lead

    1 week ago

    Parsippany, New Jersey, United States Zoetis Full time

    At Zoetis Petcare Medical Affairs, we are a dedicated team of skilled therapeutic medical professionals who collaborate closely with marketing brand managers to devise effective strategies for our product lines. Our focus is on leading medical initiatives, generating valuable data, and executing educational projects, while serving as the medical authority in...

  • Medical Affairs Manager

    4 weeks ago

    Parsippany, United States Zoetis Full time

    Zoetis Petcare Medical Affairs is composed of a group of talented therapeutic medical experts who partner with marketing brand managers to develop strategies for the brands they support, lead medical strategies, data generation plans and educational projects, and are the medical experts in reviewing and creating educational and advertising/promotional...

  • Veterinary Medical Affairs Lead

    1 week ago

    Parsippany, New Jersey, United States Zoetis Full time

    At Zoetis Petcare Medical Affairs, we are a dedicated team of skilled therapeutic medical professionals who collaborate closely with marketing brand managers to formulate strategies for the brands we support. Our responsibilities include leading medical strategies, developing data generation plans, and executing educational initiatives, while also serving as...

  • Veterinary Medical Affairs Lead

    1 week ago

    Parsippany, New Jersey, United States Zoetis Full time

    At Zoetis Petcare, the Medical Affairs division comprises a team of skilled therapeutic medical professionals who collaborate with marketing brand managers to formulate strategies for the brands they oversee. This role involves leading medical strategies, data generation initiatives, and educational projects, while serving as the medical authority in the...

  • Manager, Pharmacovigilance

    3 weeks ago

    Parsippany, New Jersey, United States Pacira Biosciences Inc. Full time

    About PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions...

  • Medical Writer, Medical Affairs

    3 days ago

    Parsippany, United States OPEN Health Full time

    Job DescriptionJob DescriptionMEDICAL WRITER, Medical Affairs Job SummaryOur Medical Writers work closely with our Medical Directors by providing research and writing support and/or repurposing technically high-level projects in support of assigned teams and new business efforts. Projects may include slide decks, infographics, web-based and social media...

  • Senior Product Manager, Global Marketing CNS

    4 weeks ago

    Parsippany, United States University of Denver Full time

    Senior Product Manager, Global Marketing CNSWayne, PA Location: Wayne, PA, US, 19087 JOB SUMMARY: The Senior Product Manager, Global Marketing CNS Cancers is a key member of the Global Product & Portfolio Strategy team. The position will help manage the brand strategy and communications for CNS indications and work on the go-to-market strategy for brain...

  • Pharmacovigilance Manager

    2 days ago

    Parsippany, New Jersey, United States Pacira Full time

    Job SummaryThe Pharmacovigilance Manager is responsible for overseeing all pharmacovigilance activities for Pacira, including the management and support of PV vendors and business partners, PV compliance monitoring, and procedural documents. This individual will work closely with internal cross-functional teams, external vendors, and partners to ensure...

  • Senior Product Manager, Global Marketing CNS

    4 weeks ago

    Parsippany, United States University of Denver Full time

    Senior Product Manager, Global Marketing CNS Wayne, PA Experienced Alumni Jobs, Full-Time Job Location: Wayne, PA, US, 19087 Philadelphia, PA, US, 19104 Portsmouth, NH, US, 03801 Parsippany, NJ, US, 07005 Portsmouth, NH, US, 03801 Wayne, PA, US, 19087 Boston, MA, US, 02114 Description: JOB SUMMARY: The Senior Product Manager, Global Marketing CNS Cancers is...

  • Lead Manager, Scientific Collaboration

    1 week ago

    Parsippany, New Jersey, United States Novocure Full time

    POSITION SUMMARY: The Lead Manager, Scientific Collaboration plays a crucial role within the Global Medical Affairs Scientific Collaboration Team, reporting directly to the Director of Scientific Collaboration for designated therapeutic areas. This role is tasked with overseeing and guiding the Global Scientific Collaboration Team to support both marketed...

  • Taxation Specialist

    5 days ago

    Parsippany, New Jersey, United States IQVIA Full time

    Key ResponsibilitiesAs a Tax Analyst at IQVIA, you will be responsible for overseeing financial and accounting operations within the organization. This role involves preparing budgets, reports, forecasts, and statutory returns, conducting financial analyses, managing taxation affairs, and ensuring compliance with regulatory standards.Essential...

  • Clinical Development Director

    7 days ago

    Parsippany, New Jersey, United States Teva Pharmaceuticals Full time

    About the RoleThe Director, Clinical Development will be responsible for leading the development, execution, and management of several clinical programs worldwide across all phases of clinical research. This role will oversee study teams and lead cross-functional teams in a matrix environment.Key ResponsibilitiesDevelop and execute clinical development...

  • Manager, Pharmacovigilance

    4 weeks ago

    Parsippany-Troy Hills, United States Pacira Full time

    Summary: The Manager, Pharmacovigilance is responsible for supporting all pharmacovigilance (PV) activities for the company, including the management and support of PV vendors and business partners, PV compliance monitoring, PV procedural documents (. SOPs, Work Instructions), and assist in coordination of training on handling of safety related...

  • Lead Manager, Cell Therapy Operations

    1 week ago

    Parsippany, New Jersey, United States Pierre Fabre Full time

    Your Role Lead Manager, Cell Therapy Operations Pierre Fabre, a prominent player in the pharmaceutical industry and a leader in dermo-cosmetics, invites you to embark on a meaningful career journey. As a company deeply rooted in oncology and primarily owned by The Pierre Fabre Foundation, we are committed to making a positive impact on health and...

  • Director Clinical Development

    1 month ago

    Parsippany, New Jersey, United States Tevapharm Full time

    Director Clinical Development – Respiratory Date: Aug 2, 2024Location: Parsippany, United States, New Jersey, 07054Job Id: 57466 Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich,...