Manager – International Regulatory Lead
Location: Hyderabad, India
Work Mode: On-site
Job ID: R-234196
Category: Regulatory Affairs
Posted On: January 22, 2026
About Amgen
Amgen is a global biotechnology leader committed to discovering, developing, manufacturing, and delivering innovative medicines that address some of the world’s most serious diseases. With more than four decades of scientific leadership, Amgen combines advanced biology, cutting-edge technology, and human genetic data to transform patient care worldwide.
Role Overview
The Manager – International Regulatory Lead (IRL) provides strategic regulatory leadership and subject-matter expertise for international markets across one or more Amgen products. This role partners closely with global, regional, and local regulatory teams to support product development, regulatory approvals, registrations, and lifecycle management across international regions.
The position plays a critical role in shaping international regulatory strategies, advising global development teams, and ensuring regulatory compliance while optimizing timelines for clinical and commercial milestones.
Key Responsibilities
Provide regulatory guidance to global teams on international regulatory requirements impacting clinical development and marketing authorization strategies.
Develop and execute international regulatory strategies to support product development, registration, and lifecycle management activities.
Advise on and support international regulatory pathways, including expedited programs, orphan drug designations, pediatric plans, compassionate use, and regulatory reliance mechanisms.
Plan and manage regulatory submissions such as clinical trial applications, marketing authorization applications, and post-approval variations.
Contribute to international regulatory strategy documents, including filing plans, risk assessments, contingency strategies, and probability-of-success evaluations.
Prepare, review, and maintain clinical and marketing application documentation (excluding CMC content) to support regulatory filings.
Lead international labeling submission strategies and manage cross-functional negotiations related to label deviations and outcomes.
Support local regulatory teams by addressing health authority queries and leveraging existing regulatory knowledge and precedents.
Actively participate in Global Regulatory Teams (GRTs) and global clinical and labeling-focused forums.
Monitor evolving global regulatory legislation, policies, and guidance relevant to assigned products.
Conduct regulatory intelligence and research to support regional and international product advancement.
Required Qualifications & Experience
Master’s degree in a scientific, pharmaceutical, or related discipline.
Minimum 8 years of relevant experience in regional and/or international regulatory affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting clinical development programs, marketing applications, and regulatory lifecycle activities.
Must-Have Skills
Strong knowledge of international regulatory frameworks for clinical trials, marketing authorizations, variations, and product labeling.
Experience with biotechnology and/or oncology regulatory submissions.
In-depth understanding of global regulatory principles and their impact on cross-functional development programs.
Familiarity with regulatory procedures and challenges across international markets.
Good-to-Have Skills
Proven ability to resolve complex regulatory issues and manage competing priorities.
Cultural awareness and ability to collaborate effectively across regions and international boundaries.
Soft Skills
Excellent written and verbal communication skills.
Ability to interpret and communicate scientific and clinical data clearly.
Strong collaboration skills in global and virtual team environments.
High level of initiative, organization, and accountability.
Effective negotiation and influencing capabilities with cross-functional stakeholders.
Equal Opportunity Employer
Amgen is an Equal Opportunity Employer and is committed to providing a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations are available for individuals with disabilities throughout the recruitment process.
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Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
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 |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
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 :
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Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
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Saarbrucken |Switzerland :
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Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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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 :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
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Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Be'Er Sheva | Yavne | Kfar Saba | Netanya |Remote :
Regulatory Labeling Manager (NA and LATAM Only) | Texas | McFarland | Hammond | Bishop | Castlebar | Switzerland | Manipal | Tulsa | Belgium | Lousiana | Remote, USA | Leinster | Thailand | Zaragoza | Bountiful | Medan | Remote - Africa | Blue Bell | Hungary | Ireland | Remote - Middle East | Xzagreb | Riga | Melbourne | Springville | Remote | Lenexa | Green Way | Minnesota | Nairobi | Slovakia | Victoria | Remote - Europe | Faridabad | French | Remote - South America (Latin Americal) |Republic of Colombia :
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Riyadh | Rabigh | King Abdullah Economic City | Najran | Jeddah | Khulais |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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