Location: IND-Gurugram-Hybrid
Regulatory Consultant (CMC/ EU Market Exp) – Syneos Health
Syneos Health, a global leader in integrated biopharmaceutical solutions, is hiring a Regulatory Consultant specializing in Chemistry, Manufacturing, and Controls (CMC) with EU market experience. This is a hybrid role based in Gurugram, India. Ideal for professionals in pharmaceutical regulatory affairs, this role offers excellent exposure to global drug development and regulatory compliance. Salary is competitive within the industry, typically ranging from INR 8–15 LPA depending on experience.
Syneos Health® partners with top pharma and biotech companies worldwide, combining clinical development, medical affairs, and commercialization expertise to accelerate innovation and improve patient outcomes.
Job Summary:
This opportunity is designed for experienced regulatory affairs professionals with a strong background in CMC and European regulatory submissions. The role involves developing, reviewing, and managing high-quality regulatory documents to support global drug development, ensuring compliance with EMA, ICH, and EU regulations.
Responsibilities:
Prepare, review, and submit regulatory documents (CMC modules) for EU markets.
Ensure compliance with ICH, EMA, and regional guidelines.
Support lifecycle management of pharmaceutical products including variations, renewals, and MAAs.
Collaborate cross-functionally with clinical, quality, and R&D teams to align regulatory strategies.
Provide regulatory guidance on CMC-related activities throughout product development.
Monitor evolving EU regulatory requirements and advise stakeholders.
Participate in regulatory project planning, risk assessment, and audits.
Required Skills & Qualifications:
Master’s or higher degree in Pharmacy, Life Sciences, or related field.
3–5 years of experience in CMC regulatory affairs, specifically with EU submissions.
In-depth knowledge of EMA and EU guidelines.
Strong understanding of ICH, GVP, and GMP compliance.
Experience with Module 3 preparation and eCTD submissions.
Excellent skills in medical writing, documentation, and regulatory project management.
Familiarity with PV software, regulatory databases, and submission tools.
Strong communication and stakeholder management skills.
Perks & Benefits:
Competitive salary packages aligned with industry standards.
Hybrid work model offering flexibility.
Global exposure to leading pharma and biotech projects.
Learning and development programs to enhance regulatory expertise.
Collaborative work culture with industry experts.
Health insurance and wellness benefits.
Company Overview:
Syneos Health® is a leading biopharmaceutical solutions organization that accelerates customer success by integrating clinical development, regulatory consulting, and commercial expertise. With operations in over 110 countries, the company partners with pharmaceutical and biotech innovators to bring life-changing therapies to patients faster.
This role is hybrid, based in Gurugram, offering a mix of remote and on-site flexibility. If you are an ambitious regulatory affairs professional with CMC and EU market expertise, this is your chance to join a global leader and advance your career in pharma regulatory consulting.
Apply now and take the next step toward shaping the future of global drug development with Syneos Health.
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Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Pondicherry (Puducherry) :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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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 :
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 | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
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Atlanta | Augusta | Rome |Hawaii :
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Boise |Illinois :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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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 | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Kiel |Belgium :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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North York | Uxbridge | Mississauga | Richmond Hill | Australia | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
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North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Tel Aviv | Netanya | Yavne | Be'Er Sheva |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
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Ciudad de México |North Island :
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Warsaw |Remote :
Medan | Belgium | Hammond | Lousiana | Remote - Africa | Thailand | Manipal | Ireland | Blue Bell | Leinster | Switzerland | Lenexa | Remote, USA | Minnesota | Remote - Europe | Remote | Remote - South America (Latin Americal) | Nairobi | Slovakia | Texas | Castlebar | Bountiful | Bishop | Remote - Middle East | French | McFarland | Hungary | Faridabad | Zaragoza | Victoria | Springville | Riga | Tulsa | Green Way | Xzagreb | Melbourne |Bucharest :
Bucharest |Makkah :
Rabigh | Khulais | Jeddah | King Abdullah Economic City | Riyadh | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |