PHARMAFull-time
Manager CMC Regulatory Affairs
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 9/18/2026
PHARMAFull-time
HIRING ORGANIZATIONREGENERONBiopharmaceuticals
ROLE OVERVIEW
Manager-level CMC Regulatory Affairs role supporting global clinical regulatory submissions, CMC compliance, investigational product release, cross-functional coordination, and team leadership in Hyderabad.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage the regulatory submission form process for global clinical trial lot release
- •review submission documentation against current and approved regulatory requirements
- •support cross-functional teams on global CTA regulatory landscapes
- •identify and communicate CMC regulatory issues
- •develop procedures and tracking systems for submission packages and approvals
- •lead meetings and presentations on complex regulatory matters
- •prepare regulatory justifications and communicate strategy and project status
- •manage and lead a team
Reporting Hierarchy: Reports within Regeneron's CMC Regulatory Affairs organization and collaborates with Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, Quality, IOPS, and Global Development stakeholders.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- BS/BA in Chemistry, Biology, or related field
- 7-9 years of experience in biopharmaceutical manufacturing or related industry
- experience in regulatory or compliance activities
- minimum 2 years leadership or managerial experience
- strong communication, negotiation, collaboration, and compliance capabilities
PREFERRED QUALIFICATIONS
- •Advanced degree in a relevant scientific field
- •strong compliance background
- •program management experience
- •understanding of quality principles in regulated manufacturing environments
- •experience with process improvement and complex CMC regulatory issues
REQUIRED VERIFIED SKILLS
CMC regulatory affairs
regulatory submissions
global CTA requirements
regulatory compliance
biopharmaceutical manufacturing
clinical trial submissions
investigational product release
quality systems
regulatory strategy
stakeholder management
team leadership
project management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Bonus & Equity: Annual bonuses or other incentive plans; equity awards
Benefits: Competitive and comprehensive total rewards may include annual incentives, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits; exact package varies by country and role.
The posting states that salary ranges may be disclosed where required by country, but no India-specific salary amount or range is provided here. Annual bonuses and other incentive plans are explicitly mentioned, but no monetary value is disclosed.
ORGANIZATION CONTEXT & CULTURE
Regeneron is a science-driven biotechnology company focused on discovering, developing, and commercializing medicines for serious diseases through innovative research, development, manufacturing, and commercialization.
TEAM SIZE: 10,000+ employees globally
INDUSTRY: Biopharmaceuticals
Culture: Science-driven, collaborative, inclusive, patient-focused, and innovation-oriented culture emphasizing teamwork, continuous improvement, and meaningful scientific impact.
EXPECTED CAREER ROADMAP
Provides progression toward Senior Manager, Associate Director, or broader CMC Regulatory Affairs leadership roles, with opportunities to deepen global regulatory strategy, submission management, compliance, and people leadership expertise.
APPLICATION ADVISORY
Highlight 7-9+ years of biopharmaceutical manufacturing and regulatory/compliance experience, at least 2 years of people leadership, global CTA knowledge, CMC submission experience, quality/compliance expertise, and examples of cross-functional problem solving and process improvement.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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