π Regulatory Consultant (EU Market Experience) | Syneos Health
π Location: Gurugram, India
π Leading Biopharmaceutical Solutions Organization
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With a focus on clinical, medical affairs, and commercial insights, we are dedicated to making a difference in the lives of patients globally.
As a Regulatory Consultant, you will be responsible for ensuring regulatory compliance in EU market submissions. The role involves conducting regulatory research, preparing submission documents, and offering support on a range of regulatory activities. If you have CMC module 3 experience and a passion for advancing therapies, this opportunity is for you!
β Regulatory Submissions: Prepare and manage components for regulatory agency submissions (e.g., IND, NDA, MAA, PMA, CTD).
β Gap Analysis & Planning: Conduct research and prepare gap analyses and product development plans.
β Multidisciplinary Team Support: Collaborate on project teams to guide the product lifecycle.
β Client & Proposal Support: Contribute to business development, including proposal preparation and client meetings.
β Project & Compliance Management: Oversee regulatory project activities, ensuring adherence to timelines, budgets, and global requirements.
β Training & SOP Development: Prepare training materials, share best practices, and contribute to SOPs and process documentation.
β Audit Support: Participate in internal and external audits, offering regulatory guidance.
π BS or PhD in a science-related field or equivalent regulatory/medical writing experience.
π 3+ years of CMC module 3 experience for EU market.
π Proven experience in regulatory submissions (IND, NDA, MAA, CTD, electronic submissions).
π Strong communication, organizational, and analytical skills.
π Proficiency in Microsoft Office and regulatory management tools.
π Fluent in English (written and spoken).
π Customer-focused, with the ability to work independently or within teams.
π Career Development: Advance through career progression, training, and recognition programs.
π Diversity & Inclusion: Be part of a global team fostering a Total Self culture.
πΌ Impact: Work on groundbreaking clinical trials and have your efforts contribute to 93% of all Novel FDA-approved drugs.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
Bhubaneswar | Rourkela |PAN-India :
Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |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 | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | 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 :
Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
New Hampshire |Ohio :
Cincinnati | Cleveland | Columbus, | Dayton | Erie | Franklin | Hamilton | Huber Heights | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Portugal :
Lisbon | Oeiras | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
Charleston |Tennessee :
Memphis | Nashville |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |United states :
fairmont | Georgia | OH | United States |United States :
Hawai | kentucky | Sylmar | Woonsocket |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |WI :
Madison | Wausau |Wisconsin :
Portage |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der RiΓ | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Kiel |Belgium :
Wavre |BULGARIA :
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France | Latvia | Lendava | Leuven | Poland | Spain |Finland :
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Basel | Zurich |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Remote Australia |Republic of Western Australia :
Nedlands |Cork :
Ringaskiddy |County Dublin :
Swords |DΓΊn Laoghaire :
DΓΊn Laoghaire |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Richmond Hill | Mississauga | Renfrew | North York | Uxbridge |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
Harlow | Stevenage | Stirling | United Kingdom | Salt Lake City | London | England | Maidenhead | Leeds |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Yavne | Netanya | Kfar Saba | Be'Er Sheva | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de MΓ©xico |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote | Remote, USA | Remote - South America (Latin Americal) | Remote - Middle East | Remote - Europe | Remote - Africa | Switzerland |Bucharest :
Bucharest |Makkah :
King Abdullah Economic City | Rabigh | Khulais | Riyadh | Najran | Jeddah |NiΕ‘ava District :
NiΕ‘ |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |HΓ Nα»i :
HΓ Nα»i | Hanoi |Ho Chi Minh :
Ho Chi Minh City |