Regulatory Consultant – EU Market (CMC Module 3)
Location: Gurugram, India (Hybrid)
Job ID: 25105260
Date Posted: February 3, 2026
Experience Required: Minimum 4–5 years in Regulatory Affairs (Pharmaceutical/Medical Device Industry)
About the Company
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating customer success by transforming clinical, medical affairs, and commercial insights into measurable outcomes. The organization follows a patient-centric Clinical Development model designed to streamline processes, improve collaboration, and enhance healthcare innovation.
With a global workforce of more than 29,000 employees across 110 countries, Syneos Health partners with healthcare organizations to deliver therapies faster and improve patient outcomes. The company promotes innovation, operational excellence, and a collaborative work culture to address evolving market challenges in the life sciences industry.
Why Join Syneos Health
Syneos Health provides strong career development opportunities through structured training programs, supportive leadership, and professional growth initiatives. The organization fosters a diverse and inclusive workplace environment through its “Total Self” culture, encouraging employees to contribute authentically while delivering high-quality work.
Employees benefit from continuous learning opportunities, recognition programs, and comprehensive rewards, creating an environment that supports both professional and personal development.
Role Overview
The Regulatory Consultant (EU Market, CMC Module 3) is responsible for supporting global regulatory strategies, particularly related to Chemistry, Manufacturing, and Controls (CMC) documentation and lifecycle management activities. The role involves preparing regulatory submissions, conducting gap analyses, ensuring compliance with global regulatory standards, and supporting product registration and post-approval activities in European Union and GCC markets.
This position requires expertise in regulatory documentation, product lifecycle management, and regulatory agency interactions, along with the ability to manage multiple projects within defined timelines and regulatory frameworks.
Key Responsibilities
Author and manage CMC Module 3 documentation, including post-approval variations and lifecycle management activities.
Conduct research on existing product data to support gap analyses, product development plans, and regulatory submission strategies.
Prepare administrative and technical documentation for regulatory agency submissions, including IND, pre-approval packages, product registrations, and post-approval maintenance activities.
Support preparation of briefing documents for regulatory agency meetings and scientific advice processes.
Manage day-to-day regulatory activities for assigned projects in accordance with timelines, scope, and budget requirements.
Collaborate with cross-functional teams, including clinical and technical experts, to support product development throughout the lifecycle.
Provide subject matter expertise and troubleshooting support for regulatory challenges and project-related issues.
Prepare cost estimates for regulatory services and support business development and client engagement activities.
Ensure compliance with global regulatory standards, company policies, and quality processes.
Develop training materials and share regulatory best practices internally and externally.
Support internal and external audits, cross-functional initiatives, and regulatory process improvements.
Contribute to the development and maintenance of standard operating procedures (SOPs) and related documentation.
Provide oversight and guidance to team members on regulatory project execution.
Maintain training records and complete required professional development programs.
Required Qualifications and Skills
Master of Pharmacy (MPharm) or equivalent degree in pharmaceutical sciences, life sciences, or related discipline.
Minimum 4–5 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
Proven experience in CMC Module 3 authoring, post-approval variations, and product lifecycle management.
Experience working with EU and GCC regulatory markets.
Demonstrated experience in preparing regulatory submissions such as IND, NDA, MAA, PMA, CTD, and electronic submissions.
Strong understanding of global regulatory requirements and compliance standards.
Excellent written and verbal communication skills with strong scientific documentation abilities.
Proficiency in Microsoft Office applications and regulatory documentation tools.
Strong analytical, organizational, and problem-solving skills with attention to detail.
Ability to work independently and collaboratively within cross-functional teams.
Fluency in English (written and spoken).
Company Impact and Global Presence
Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, conducting more than 200 studies across 73,000 sites involving over 675,000 clinical trial participants. The organization continues to play a critical role in advancing innovative therapies and improving global healthcare delivery.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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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 :
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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 :
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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 :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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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Swords |Republic of China :
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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 :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Argentina | Peru |Brazil :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Netanya | Yavne | Tel Aviv | Be'Er Sheva |Remote :
Victoria | Green Way | Tulsa | Hammond | Remote - Middle East | Remote, USA | Zaragoza | Leinster | Hungary | Xzagreb | Belgium | Blue Bell | Remote - South America (Latin Americal) | Riga | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Manipal | Medan | Faridabad | Ireland | Nairobi | Springville | Castlebar | Texas | Switzerland | Slovakia | Lenexa | French | Bountiful | Lousiana | Remote - Africa | Remote | Melbourne | Remote - Europe | Minnesota | Thailand | McFarland |Republic of Colombia :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Najran | Riyadh | King Abdullah Economic City | Khulais | Jeddah | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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