Regulatory Consultant (CMC Module 3) – Structured Job Format
Job Overview
Position: Regulatory Affairs Consultant / Senior Regulatory Consultant (CMC)
Company: Syneos Health
Location: IND-Remote
Job ID: 25106904
Updated: May 18, 2026
Department: Regulatory Affairs / CMC
Work Mode: Remote
About the Company
Syneos Health is a leading global life sciences services organization supporting pharmaceutical and biotechnology companies across drug development and commercialization.
Company highlights:
Supported 94% of novel FDA-approved drugs over the past 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 lifecycle management activities
Managing post-approval regulatory variations
Coordinating with global cross-functional stakeholders
Ensuring timely and compliant regulatory submissions
The role requires strong expertise in Module 3 authoring, EU regulations, and post-approval CMC lifecycle management for pharmaceutical products.
Key Responsibilities
CMC Documentation & Authoring
Author and review:
Module 3 (CMC) documentation
Regulatory submission content
Lifecycle management documents
Support post-approval submission activities
Lifecycle Management & Variations
Prepare and support:
EU Type IA, IB, II variations
US CBE and PAS submissions
ROW (Rest of World) variations
Handle:
API-related changes
Drug Product (DP) variations
Site Transfer & Regulatory Strategy
Manage site transfer submissions
Compile regulatory documentation
Support submission strategy planning
Cross-Functional Collaboration
Collaborate with:
Manufacturing
Quality Assurance (QA)
Quality Control (QC)
Supply Chain teams
Collect and verify technical and regulatory information
Regulatory Operations & Compliance
Track assigned regulatory activities
Ensure:
Timely submissions
Compliance with regulatory requirements
Adherence to project timelines
Maintain high-quality deliverables
Regulatory Query Management
Respond to:
Health authority deficiencies
Regulatory questions
Submission queries
Ensure timely and accurate responses
Client & Stakeholder Interaction
Participate in:
Client meetings
Cross-functional discussions
Regulatory strategy meetings
Represent regulatory affairs function for assigned projects
Technical Support & Guidance
Provide:
Technical troubleshooting support
Regulatory guidance to team members
Expertise in CMC activities
Project & Budget Management
Support compliance with:
Project scope
Timelines
Budget expectations
Manage multiple priorities independently
Required Qualifications
Educational Background
M.Pharm
M.Sc.
Equivalent Life Sciences degree
Experience Requirements
6–12 years of experience in Regulatory Affairs
Strong hands-on expertise in:
CMC authoring
Post-approval lifecycle management
Global regulatory submissions
Required Skills & Expertise
Regulatory & CMC Expertise
Strong experience in:
Module 3 (CMC) authoring and review
Lifecycle management activities
Regulatory variation submissions
Expertise in:
EU regulatory requirements (mandatory)
ROW market submissions
Product & Submission Knowledge
Experience handling:
API variations
Drug Product (DP) variations
Knowledge of:
eCTD submissions
Regulatory publishing tools
Submission systems
Stakeholder Management
Strong communication and collaboration skills
Experience working with:
Global stakeholders
Clients
Cross-functional teams
Preferred Competencies
Site transfer submission expertise
Independent project execution
Regulatory strategy support experience
Ability to manage multiple projects simultaneously
Strong problem-solving and troubleshooting skills
Soft Skills
Excellent written and verbal communication
Strong organizational and tracking skills
Detail-oriented approach
Ability to work independently
Strong prioritization and multitasking abilities
Work Environment & Culture
Why Join Syneos Health?
Career development and progression opportunities
Inclusive and collaborative culture
Technical and therapeutic-area training
Global regulatory project exposure
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 ownership
Cross-functional collaboration
Client-facing responsibilities
Organizational Impact
This role directly contributes to:
Successful global submissions
Regulatory compliance
Product lifecycle management
High-quality regulatory deliverables
Ideal Candidate Profile
The ideal candidate should:
Have strong expertise in CMC Module 3 authoring
Understand EU and global regulatory frameworks
Manage lifecycle activities independently
Handle regulatory authority interactions effectively
Coordinate well with cross-functional teams
Deliver 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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Remote, India | Siliguri |Illinois :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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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 :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
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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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Wavre |Tipperary :
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Leiden |Netherlands :
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 :
Vienna |Catalonia :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Warsaw |
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