PHARMAFull-time
Regulatory Affairs Specialist
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 8/21/2026
PHARMAFull-time
HIRING ORGANIZATIONLONZALife Sciences / Pharmaceutical Manufacturing / Healthcare Technology
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
Join Lonza’s Global Capability Center (GCC) in Hyderabad as a Regulatory Affairs Specialist (CMC). In this hybrid role, you will be responsible for site and customer CMC regulatory writing activities for global clinical trial applications (CTA/IND/IMPD) and product lifecycle management across advanced biologics, bioconjugates, cell and gene therapies, microbial systems, and vaccines.
Core Responsibilities
CMC Dossier Authoring: Author, edit, and compile high-quality Chemistry, Manufacturing, and Controls (CMC) regulatory dossiers for clinical trial applications and commercial filings using technical source documents.
Specialized Modality Support: Write and update CMC sections across specialized biopharmaceutical modalities including Bioconjugates, Microbial systems, Cell & Gene Therapy (CGT), Vaccines, and Biological products.
Lifecycle Management: Support post-approval variations, lifecycle maintenance, and annual reports for commercial products.
Global Submission Coordination: Partner with Lonza’s network regulatory teams, quality units, and customer stakeholders worldwide to align submission schedules and deliver successful regulatory outcomes.
Regulatory Compliance & Publishing: Manage regulatory documents and submission components within electronic document management systems (EDMS) adhering to global eCTD standards and health authority expectations.
Technical & Systems Expertise
Strong working knowledge of global regulatory guidelines (FDA, EMA, ICH) pertaining to CMC documentation.
Hands-on proficiency with Veeva Vault RIM/EDMS, eCTD publishing platforms, and electronic document repositories.
Total Rewards & Benefits
Hybrid working model with comprehensive family relocation assistance available for eligible candidates.
Performance-driven compensation programs, competitive health benefits, and continuous global learning opportunities.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
CMC Writing
Clinical Trial Applications (CTA)
eCTD Publishing
Veeva Vault
Biologics
Cell & Gene Therapy
Vaccines
Product Lifecycle Management
Health Authority Submissions
Regulatory Compliance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Lonza is actively hiring for this position.
INDUSTRY: Life Sciences / Pharmaceutical Manufacturing / Healthcare Technology
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.