Dir Regulatory Affairs at Teva Pharmaceutical Industries Ltd. - Israel

Navi Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, FDA Regulations, Leadership, Pharmaceutical Industry, Lifecycle Management, CMC Submissions, Regulatory Strategy, Team Management, Communication Skills, Regulatory Intelligence, Negotiation Skills, Matrixed Environment, Lean Six Sigma, Training Programs, Compliance, Business Acumen

Industry

Pharmaceutical Manufacturing

Description

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 The Director, Regulatory Affairs – Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U.S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners.How you’ll spend your day Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations. Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams. Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc. Establish and maintain strong relationships with FDA project managers. Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes. Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization. Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning. Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives. Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book. Your experience and qualifications Pharm D or M. Pharma in a scientific discipline. Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products. Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains. Deep expertise and applied knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards. Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree). Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs. Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance. Demonstrates a basic understanding of pharmaceutical drug development. Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills. Demonstrates excellent verbal and written communication skills. Experience working in a matrixed, multinational environment, as well as with third parties. Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus. Lean Six Sigma certification, or other accreditation related to improving business processes is a plus. 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 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.

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Responsibilities

The Director of Regulatory Affairs is responsible for setting the strategic direction and executing post-approval regulatory activities for U.S. FDA-regulated generic drug products. This includes overseeing regulatory filings, leading a team, and ensuring compliance with FDA regulations.