This role requires an experienced professional with 8-9 years of expertise in managing the pre- and post-approval life cycle of biologic products across various regulated markets (EU, US, Canada) and emerging markets. The candidate will have a strong understanding of regulatory frameworks, regional trends, and will contribute to compiling, submitting, and obtaining approvals for country-specific submission files. This includes the preparation and delivery of both simple and complex regulatory maintenance submissions. The candidate will support affiliates with local requirements and guidance from regulatory agencies, ensuring compliance with international regulatory guidelines.
Regulatory Life Cycle Management:
Submission Preparation & Filing:
Affiliate Support:
Submission Planning & Tracking:
Regulatory Information Management:
Effective Communication:
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Brisbane | California | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | Menlo Park | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Bridgeport | Enfield | Groton | Storrs |D.C :
Washington |Florida :
Clearwater | Coral Gables | Daytona Beach | Gainesville | Jacksonville | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Park RIdge | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Garden city | Lawrence |Kenlucky :
Shelbyville |Kington :
Frank Scottile Blvd |LA :
Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maryland :
Baltimore | Elkridge | Gaithersburg | Rockville |Massachusetts :
Andover | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | St. Louis |Nevada :
Las Vegas |New Hampshire :
Lebanon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New Mexico :
Santa Fe |New York :
Albany | Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |North Dakota :
Dickinson |Ohio :
Cincinnati | Cleveland | Columbus, | Macedonia |Oklahoma :
Oklahoma City |Oregon :
Bend | Corvallis | Eugene | Roseburg | Salem | Springfield |Pennsylvania :
Ambler | Collegeville | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
Lisbon | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
Charleston |Tennessee :
Nashville |Texas :
Abilene | Austin | Bulverde | Corsicana | Dallas | Houston | Longview | Plano | Richardson | San Antonio | Tyler | Waco |United states :
Georgia | United States |United States :
Hawai | Sylmar |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bothell | Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |BULGARIA :
Bulgaria |Denmark :
Copenhagen |Europe :
Latvia | Leuven | Poland | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Buenos Aires :
Buenos Aires |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Antwerp :
Heist op den Berg |Brussels :
Brussels |Canada :
Canada |Ontario :
Richmond Hill | North York |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |United Kingdom :
Harlow | London | Stirling | Leeds | Maidenhead | Salt Lake City |Estonia :
Estonia |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Jakarta :
Jakarta |Cork :
Ringaskiddy |County Dublin :
Swords |Republic of Ireland :
Waterford | Dublin | Limerick |Israel :
Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Tokyo :
Otemachi |Kazakhstan :
Almaty |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |Philippines :
Manila |Remote :
Remote, USA | Remote | Remote - Europe | Switzerland |Makkah :
Jeddah | Rabigh | Khulais | Riyadh | Najran |Singapore :
Singapore |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Dubai :
Dubai |