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Sr Regulatory Consultant (CMC, EU mkt) (Office based)

By Admin · Regulatory Affairs

HYDERABAD (IN)HYBRIDPOSTED: 10/2/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
Syneos Health

ROLE OVERVIEW

Lead and contribute to regulatory consulting projects with a strong focus on CMC regulatory strategy, EU market requirements, post-approval variations, lifecycle management, and regulatory submissions for pharmaceutical products.

ROLE DEFINITION & RESPONSIBILITIES

  • •Author and review Module 3 CMC sections for post-approval variations and lifecycle activities
  • •Handle EU and ROW CMC variation submissions
  • •Manage regulatory activities involving drug substance, drug product, and site transfer variations
  • •Contribute technical expertise to regulatory project teams and client engagements
  • •Conduct regulatory research and provide operational advice to clients
  • •Prepare regulatory submissions, reports, dossiers, and other regulatory documents
  • •Participate in regulatory agency and client meetings
  • •Support quality improvement, regulatory systems, internal training, and business development activities
Reporting Hierarchy: Contributes to the GRAS regulatory department and project teams; interacts with internal departments, clients, technical experts, and regulatory agencies; may act as a Line Manager for a small team depending on location

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • 6-9 years of Regulatory Affairs experience
  • Strong expertise in Module 3 CMC sections
  • Experience with EU and ROW CMC variation submissions
  • Hands-on experience with drug substance, drug product, and site transfer variations
  • Strong knowledge of global regulatory requirements with mandatory EU market experience
  • Bachelor's degree in a science-related field or equivalent experience
  • Experience contributing to regulatory submissions such as IND, PMA, NDA, MAA, or CTD
  • Excellent written and verbal English communication
  • Strong analytical, problem-solving, quality management, and organizational skills

PREFERRED QUALIFICATIONS

  • •Experience in biologics
  • •PhD or advanced scientific degree
  • •Experience with niche submissions such as ODD, PIP/PMP
  • •Regulatory medical writing experience
  • •Experience with electronic submissions
  • •Experience in pharmaceutical or medical device regulatory consulting

REQUIRED VERIFIED SKILLS

Regulatory Affairs
CMC
Module 3
EU regulatory requirements
ROW CMC variations
drug substance
drug product
site transfer
post-approval variations
lifecycle management
IND
PMA
NDA
MAA
CTD
regulatory submissions
regulatory research
regulatory strategy
client consulting
Microsoft Office

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards program.
The provided posting does not disclose salary or bonus/equity information. Compensation should therefore be treated as undisclosed rather than estimated.

ORGANIZATION CONTEXT & CULTURE

Syneos Health is a fully integrated life sciences services organization supporting drug development and commercialization and providing regulatory, clinical, and other services to pharmaceutical and healthcare innovators.

TEAM SIZE: 25,000+ colleagues
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Syneos Health emphasizes agile collaboration, professional development, customer-focused delivery, innovation, inclusion, and strong cross-functional teamwork.

EXPECTED CAREER ROADMAP

The role can progress toward Principal Regulatory Consultant, Regulatory Affairs Project Lead, Associate Director/Director-level regulatory consulting, or broader CMC regulatory strategy leadership roles. Opportunities may also expand into people management and global client-facing regulatory leadership.

APPLICATION ADVISORY

Emphasize 6–9 years of Regulatory Affairs experience; clearly demonstrate EU market expertise and Module 3 CMC authoring/review; highlight post-approval variation, lifecycle management, drug substance, drug product, and site transfer experience; list relevant submission experience such as MAA, NDA, IND, and CTD; demonstrate client-facing communication, regulatory research, and project management skills.
RECOMMENDED TRAINING
1/5
CMC Regulatory Affairs Certification

CMC Regulatory Affairs Certification

READY TO SUBMIT?

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