Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job ID: 63035
Experience Required: 15+ years (10+ years in U.S. Regulatory Affairs)
Job Category: Regulatory Affairs / Pharmaceutical Leadership
Job Type: Full-Time, Permanent
Teva Pharmaceuticals is a global leader in innovative biopharmaceuticals and world-class generics. We focus on improving patient health worldwide, from neuroscience and immunology innovations to high-quality medicines delivered globally. At Teva, you will be part of a collaborative, inclusive culture that encourages professional growth, strategic thinking, and work-life balance while contributing to better health worldwide.
The Director – Regulatory Affairs (Post-Approval, U.S. Generics) is a senior regulatory leader responsible for defining and executing the strategic direction for post-approval lifecycle management of FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensures compliance with FDA regulations, and drives continuous improvement in lifecycle management processes. You will lead a team of regulatory professionals and act as a primary liaison with the FDA, internal stakeholders, and external partners.
Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs.
Oversee preparation, review, and submission of CMC post-approval regulatory filings, including CBE-0, CBE-30, PAS, Annual Reports, REMS updates, and general correspondences.
Serve as the primary regulatory authority for 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, and alternate APIs.
Establish and maintain strong relationships with FDA project managers, ensuring smooth interactions and timely approvals.
Monitor evolving FDA regulations, guidances, and enforcement trends; adapt strategies and internal processes proactively.
Develop and implement regulatory policies, SOPs, and training programs to ensure compliance and best practices.
Lead, mentor, and develop a high-performing regulatory team, fostering accountability, innovation, and continuous learning.
Represent Regulatory Affairs in global governance forums, strategic planning, and internal initiatives.
Manage notices of commercial launch, product obsoletion, and updates to the Orange Book.
Pharm.D. or M. Pharma in a scientific discipline.
Minimum 15+ years of pharmaceutical industry experience, including 10+ years in U.S. Regulatory Affairs managing post-approval portfolios.
Proven leadership with 8+ years in a supervisory role, managing large regulatory teams and complex product portfolios.
Deep expertise in FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
Experience with regulatory systems (Veeva, TrackWise) and electronic document management systems (Wisdom, Glorya, Livelink, Knowledgetree).
Track record in regulatory strategy, FDA interactions, lifecycle management, and compliance alignment with business objectives.
Strong business acumen, decision-making, and ability to influence executive leadership.
Excellent verbal and written communication skills and ability to operate in a matrixed, multinational environment.
Experience with regulatory intelligence, policy shaping, and industry advocacy.
Lean Six Sigma or equivalent accreditation in business process improvement.
Exposure to complex global supply chains and multiple dosage forms.
Competitive benefits including flexible work schedules, health support, and generous leave policies.
Career development opportunities through Teva’s Twist platform, offering learning programs, projects, and internal growth.
Inclusive, collaborative work culture that prioritizes professional growth and employee wellbeing.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Baddi | Solan |Rajasthan :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Uxbridge | Australia | Richmond Hill | Mississauga | North York |Canada :
Canada |Quebec :
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Zaventem |South America :
Argentina | Peru |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Bangkok |Israel :
Kfar Saba | Tel Aviv | Yavne | Netanya | Be'Er Sheva |Remote :
Springville | Remote | Nairobi | Remote, USA | Medan | McFarland | Regulatory Labeling Manager (NA and LATAM Only) | Switzerland | Lousiana | Remote - South America (Latin Americal) | Texas | Xzagreb | Remote - Africa | Riga | Melbourne | Minnesota | Belgium | Tulsa | Castlebar | Ireland | Hungary | Lenexa | French | Leinster | Green Way | Thailand | Bountiful | Faridabad | Zaragoza | Bishop | Remote - Europe | Manipal | Hammond | Blue Bell | Slovakia | Remote - Middle East | Victoria |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Riyadh | King Abdullah Economic City | Khulais | Jeddah | Rabigh | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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