PHARMAFull-time
Regulatory Manager
DELHI NCR (IN)REMOTEPOSTED: 8/20/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Team Leadership & Project Strategy: Serve as the functional regulatory lead directing project teams, conducting risk assessments, driving strategic decision-making, and managing project scope, budgets, and timelines.
CMC & Lifecycle Management: Author CMC Section Module 3, manage post-approval variations, and oversee product lifecycle management activities across global jurisdictions, particularly EU and GCC markets.
Regulatory Submissions & Strategy: Research global regulatory requirements, perform gap analyses, create product development plans, and author technical/administrative submission packages (IND, PMA, NDA, MAA, CTD).
Stakeholder & Agency Interactions: Prepare briefing documents for scientific advice and regulatory agency meetings, manage internal and external stakeholders, and support client business development initiatives.
Quality & Process Improvement: Act as a subject matter expert for troubleshooting technical regulatory issues, conduct project audits, maintain SOPs, and provide mentorship and oversight to junior team members.
Technical & Domain Standards
Regional Market Expertise: Proven regulatory strategy and submission experience in EU and GCC markets.
Submissions & Authoring: Expertise in Module 3 CMC, post-approval changes, gap analysis, and electronic CTD (eCTD) submission frameworks.
Education Requirement: Mandatory M. Pharm (Master of Pharmacy) or equivalent advanced life sciences degree.
Leadership & Impact
Functional Leadership: Direct cross-functional project teams, mentor regulatory specialists, and serve as the key regulatory authority for client discussions.
Risk & Process Management: Conduct comprehensive risk assessments and establish standardized regulatory workflows across multinational client engagements.
Benefits & Total Rewards
Workplace Flexibility: Pre-approved fully remote or hybrid setup in Gurugram.
Professional Development: Structured career pathways, leadership training, comprehensive health and wellness benefits, and global peer recognition programs.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
CMC Module 3
Post Approval Variations
Lifecycle Management
EU Market
GCC Market
eCTD
IND
NDA
MAA
Risk Assessment
Functional Leadership
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
RECOMMENDED TRAINING
1/5
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