Job Information
Teva Pharmaceuticals Manager Regulatory Affairs in Parsippany, New Jersey
Manager Regulatory Affairs
Date: Jun 14, 2024
Location:
Parsippany, United States, New Jersey, 07054
Company: Teva Pharmaceuticals
Job Id: 56073
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, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
This section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we’re in it together, and we make work fulfilling.
How you’ll spend your day
Teva Pharmaceuticals USA, Inc. is seeking multiple Managers, Regulatory Affairs (Parsippany, NJ) to evaluate change controls, provide regulatory assessment within the company system to regulatory documents, and formulate strategies with minimal guidance, to ensure proper filing categories. Compile and review high quality submissions (Abbreviated New Drug Applications/New Drug Applications, amendments, supplements, annual reports, etc.). Draft ANDA/NDA modules for original applications, amendments, supplements, etc., for FDA submission. Draft deficiency letter responses and coordinate cross functionally (internally and externally) to obtain accurate documentation. Lead Right First Time Submissions (including ANDAs/NDAs, amendments, supplements, etc.). Maintain full awareness of all regulatory activities on assigned projects and ensure that the project deadlines and performance standards for these projects are established and met. Work with internal and external stakeholders to manage submission schedules. Update tracking sheets as needed. Contribute to the preparation of meeting packages related to pre and post ANDA/NDA meetings with FDA. Assess and remain current with new and changing guidances/regulation. Train, or mentor, team members and/or new employees. Local telecommuting permitted up to 2 days per week.
Your experience and qualifications
Requires a Bachelor’s degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience.
Must have 2 years of sterile/ parenteral dosage form experience (such as different forms of injections, ophthalmics, or otics).
Must have experience with:
Chemistry, Manufacturing and Controls (CMC) in drug development process.
Quality Target Product Profile and Critical Quality Attributes, drug composition, product and process design, various specification settings, analytical methods, analytical method validation, sterility assurance, manufacturing, stability design and stability data analysis during drug development and life cycle of drugs.
Change controls and regulatory assessment of change controls.
Software to assess change controls such as TrackWise;
FDA/ICH regulations pertaining to Generic Drug User Fee Act (GDUFA)/ Prescription User Fee ACT (PDUFA), CMC and regulatory filing aspects; Drafting correspondences to FDA.
Software (such as Liquent/ Docubridge/ eCTD Express) used in Regulatory Operations; and MS Word, MS Excel, Adobe Pro and using internet to browse FDA websites and other FDA information repositories (IIG database, Orange Book, Drug Approval Database, Dailymed, Product Specific Guidance database).
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.
Apply at https://www.tevapharm.com/your-career/; reference Req. 56073.
Already 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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
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 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. We 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.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
EOE including disability/veteran