Job title: Mgr Regulatory Affairs
Company: Teva Pharmaceuticals
Job description: 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 growth!
Job Description
- Hands on leader in regard to daily work load; in addition to managerial responsibilities, this position could have independent work assignments to manage, on behalf of the team, if needed, as well as participate in the preparation of labeling submission documents in order to meet tight deadlines.
- Subject Matter Expert in the development, review, and electronic compilation of labeling documents to align with the Reference Listed Drug, FDA solicited safety changes, company goals, and submission requirements for assigned ANDAs / 505b2s and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents as well as preparing full labeling responses to FDA via appropriate filing mode.
- Responsible for assuring that projects are assigned to direct reports and/or external team members in order to meet departmental goals, FDA timelines, and to ensure the team adequately functions to meet all company objectives.
- Communicate, plan, prioritize, and perform training in order to ensure labeling documents are prepared to align with company goals and submission requirements for ANDAs / 505(b)2s and ensure labeling meets all legal and regulatory requirements.
- Perform in depth quality reviews of labeling and submission documents prior to final disposition.
- Maintain the labeling tracker in order to ensure all assigned projects remain on track by direct reports and re-prioritize, when needed, to ensure timely submission of assignments and accurate tracking of the projects assigned.
Job Description
- Subject Matter Expert in the development/review of Structured Product Labeling (SPL) documents (content and data elements) to ensure alignment with associated application as well as applicable FDA regulations and guidances. This includes QC, proofing, editing, and formatting of applicable sections as well as the data elements section, PDP, and site establishments, within the SPL software, in addition to troubleshooting any validation error received.
- Work with US Regulatory Labeling Team and Regulatory Operations to ensure assigned projects like RLD updates, FDA-solicited safety labeling changes, PADERs, annual reportable changes, Electronic Medication Guide or PPI initiatives, etc. and any other projects, as per requirement, are submitted on-time following the eCTD requirements related to labeling.
- Guide the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool, TVT.
- Work closely with external departments/sites including IP, Marketing, CMC team(s) and Device team(s) to align with product/device strategy impacting approved portfolio.
- Train and develop respective team members, as well as new labeling personnel, and provide guidance and leadership with regard to best practices in the US labeling arena.
- Create, 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, and standard operating procedures applicable to US Gx labeling.
- Experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities is preferred.
Qualifications
- Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience
- Total years of experience required for the role: 7+ years of experience in US labeling & + 1 year supervisory experience
- Relevant years of experience: 6 to 7 years Pharmaceutical industry experience required, specifically in Regulatory Affairs and US Gx labeling
Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
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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.
Expected salary:
Location: Navi Mumbai, Maharashtra
Job date: Thu, 10 Nov 2022 05:52:53 GMT
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