Senior Manager – Regulatory CMC, Injectables
Company: Sun Pharmaceutical Industries Ltd
Location: Gurugram / Mumbai – R&D
Department: Global Regulatory Affairs – Innovative Medicines
Employment Type: Full-Time
Experience: 15+ years of hands-on experience in Global Regulatory Affairs with strong expertise in CMC regulatory activities for Injectable (Parenteral) formulations across US, EU, Canada, and other regulated markets.
Salary Package: ₹40–60 LPA (Approx., based on current market standards; final compensation depends on leadership experience, regulatory expertise, and global submission exposure.)
Role Overview
The Senior Manager – Regulatory CMC, Injectables is responsible for providing strategic CMC regulatory leadership for branded injectable products across global markets. The role involves leading regulatory strategies, managing complex CMC submissions, supporting lifecycle management activities, and ensuring regulatory approvals and continued product supply in compliance with global regulatory requirements.
Key Responsibilities
CMC Regulatory Strategy & Leadership
Serve as the Regulatory CMC Product Lead for assigned branded injectable products.
Provide CMC regulatory leadership across Regulatory Affairs and cross-functional project teams.
Develop, communicate, and review CMC Regulatory Strategy Documents for complex development programs.
Assess regulatory risks and develop mitigation strategies to improve probability of regulatory success.
Provide regulatory input for product licensing, due diligence assessments, divestments, and product withdrawal activities.
Global Regulatory Submissions
Lead preparation, review, and execution of CMC regulatory documentation for:
PIND/IND submissions
Clinical Trial Applications (CTA)
New Drug Applications (NDA)
Marketing Authorization Applications (MAA)
Health authority background packages
Regulatory responses and deficiency letters
Ensure submission quality, compliance, and timely delivery of regulatory milestones.
Manage responses to health authority questions and regulatory commitments.
Support global regulatory submissions for US, EU, Canada, and emerging markets.
Lifecycle Management & Product Continuity
Ensure timely submission of lifecycle management activities, including:
Annual reports
Supplements
Post-approval changes
Regulatory variations
Support continued product supply through effective regulatory planning and execution.
Monitor regulatory timelines and coordinate activities with key stakeholders.
Cross-Functional Collaboration
Collaborate with:
Global manufacturing sites
Quality Assurance
Analytical Development
Manufacturing teams
Clinical teams
Commercial teams
Other R&D functions
Integrate manufacturing strategies with regulatory requirements.
Provide regulatory guidance throughout product development and commercialization.
Technical & Scientific Review
Review complex CMC documentation and scientific data packages.
Evaluate technical arguments and ensure conclusions are supported by appropriate data.
Provide regulatory guidance related to:
Sterile manufacturing processes
Parenteral formulations
Sterility testing
Analytical development
Quality systems
Identify innovative solutions for complex regulatory challenges.
Team Leadership & Mentoring
Mentor and guide junior regulatory team members.
Lead multidisciplinary teams and support effective decision-making.
Promote regulatory excellence, compliance, and continuous improvement.
Manage competing priorities while ensuring delivery of critical milestones.
Educational Qualification
Advanced degree preferred:
PhD
PharmD
MBA
M.Pharm in Pharmaceutical Sciences or related discipline
Required Experience
Minimum 15+ years of experience in Global Regulatory Affairs.
Extensive experience in Regulatory CMC for Injectable (Parenteral) products.
Strong experience with regulated markets including:
US
EU
Canada
Emerging global markets
Proven experience leading complex CMC regulatory submissions and strategies.
Experience working with global manufacturing and cross-functional teams.
Technical Skills
Expert knowledge of:
Global CMC regulatory requirements
USFDA and EMA regulations
ICH guidelines
Injectable product development and manufacturing processes
CTD/eCTD dossier preparation and review
Strong ability to critically evaluate scientific and technical documentation.
Experience managing health authority interactions and regulatory responses.
Strong understanding of sterile manufacturing, analytical testing, and quality requirements.
Leadership Competencies
Strategic thinking and regulatory decision-making ability.
Strong leadership and stakeholder management skills.
Excellent negotiation and communication skills.
Ability to manage complex global projects.
Strong problem-solving and risk assessment capabilities.
Ability to influence cross-functional teams.
Adaptability to changing business and regulatory priorities.
Strong written and verbal communication skills in English; additional languages are an advantage.
Uttar Pradesh :
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Frank Scottile Blvd |Missouri :
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Washington |Delaware :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Queensland |Melbourne :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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