Regulatory Consultant (CMC Module 3) – Structured Job Format
Job Overview
Position: Regulatory Consultant / Senior Regulatory Consultant (CMC)
Company: Syneos Health
Location: Gurugram (Hybrid)
Job ID: 25106904
Updated: May 18, 2026
Department: Regulatory Affairs / CMC
Work Mode: Hybrid / Remote Support
About the Company
Syneos Health is a global life sciences services organization supporting pharmaceutical and biotechnology companies across clinical development and commercialization.
Company highlights:
Supported 94% of novel FDA-approved drugs in the last 5 years
Worked on 95% of EMA-authorized products
Conducted 200+ studies across 73,000+ clinical sites globally
Role Summary
The Regulatory Consultant (CMC Module 3) is responsible for:
Authoring and reviewing CMC regulatory documents
Supporting global post-approval lifecycle management
Managing CMC variations and site transfer submissions
Coordinating with cross-functional and global stakeholders
Ensuring timely and compliant regulatory submissions
This role requires strong expertise in Module 3 authoring, EU regulatory requirements, and lifecycle management activities for pharmaceutical products.
Key Responsibilities
CMC Authoring & Documentation
Author and review:
Module 3 (CMC) documentation
Regulatory submission documents
Lifecycle management documentation
Support post-approval submissions and regulatory updates
Lifecycle Management & Variations
Prepare and support:
EU Type IA, IB, II variations
US CBE and PAS submissions
ROW (Rest of World) variations
Manage:
API-related changes
Drug Product (DP) variations
Site Transfer & Regulatory Strategy
Support site transfer submissions
Compile submission documentation
Contribute to regulatory strategy planning
Cross-Functional Collaboration
Coordinate with:
Manufacturing teams
Quality Assurance (QA)
Quality Control (QC)
Supply Chain teams
Collect and verify technical and regulatory data
Regulatory Compliance & Submission Management
Track assigned regulatory activities
Ensure:
Timely submissions
Regulatory compliance
Project milestone adherence
Maintain high-quality submission standards
Regulatory Query Management
Respond to:
Health authority questions
Deficiency letters
Regulatory queries
Ensure responses are submitted within required timelines
Stakeholder & Client Interaction
Participate in:
Client meetings
Cross-functional discussions
Regulatory review meetings
Serve as a regulatory representative for assigned projects
Team Support & Technical Guidance
Provide:
Technical troubleshooting support
Guidance to team members
Regulatory expertise on CMC activities
Project & Budget Management
Support project scope management
Ensure compliance with:
Timelines
Budgets
Deliverable expectations
Required Qualifications
Educational Background
M.Pharm
M.Sc.
Equivalent Life Sciences degree
Experience Requirements
6–12 years of Regulatory Affairs experience
Strong hands-on expertise in:
CMC authoring
Post-approval lifecycle management
Regulatory variations
Required Skills & Expertise
Regulatory & CMC Expertise
Strong Module 3 (CMC) authoring and review experience
Expertise in:
EU regulatory requirements (mandatory)
ROW market submissions
Experience with:
API variations
Drug Product (DP) changes
Lifecycle management activities
Submission & Regulatory Systems
Knowledge of:
eCTD submissions
Regulatory publishing tools
Submission management systems
Stakeholder Management
Strong collaboration and communication skills
Experience working with:
Global stakeholders
Clients
Cross-functional teams
Preferred Competencies
Regulatory strategy support experience
Site transfer submission expertise
Multi-project management capability
Independent execution of regulatory deliverables
Problem-solving and troubleshooting ability
Soft Skills
Excellent verbal and written communication
Strong organizational and tracking skills
Detail-oriented approach
Ability to work independently
Strong multitasking and prioritization skills
Work Environment & Culture
Why Join Syneos Health?
Career development and progression opportunities
Inclusive and collaborative work environment
Technical and therapeutic-area training
Global exposure to regulatory projects
Recognition and rewards programs
Functional Areas Covered
Regulatory Affairs
CMC Documentation
Lifecycle Management
Post-Approval Variations
eCTD Submissions
Regulatory Compliance
Global Regulatory Strategy
Seniority & Impact
Role Level
Mid-to-senior level regulatory affairs role with:
Independent project responsibilities
Cross-functional collaboration
Client-facing interactions
Organizational Impact
This role directly contributes to:
Successful global regulatory submissions
Product lifecycle compliance
Efficient variation management
Regulatory inspection readiness
Ideal Candidate Profile
The ideal candidate should:
Have strong expertise in CMC Module 3 authoring
Understand EU and global regulatory requirements
Manage lifecycle activities independently
Handle regulatory queries effectively
Coordinate efficiently with cross-functional teams
Deliver accurate and compliant submissions within timelines
Employment Notes
Additional responsibilities may be assigned as needed
Equivalent qualifications and experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations are available where appropriate
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Boise |Colorado :
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 :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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 :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 | Australia | North York | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Turku |Remote Korea :
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Warsaw |
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