R&D GRA CMC Team Lead
Sanoh India · Hyderabad · onsite · Posted 24d ago
Not disclosedFresherfulltimeSourced from
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About this role
About The Job
Our Team
The Global Regulatory Affairs GRA CMC & Device Organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls CMC and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's Take the Lead values, particularly in Leading Together and Being Bold, mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.
Main responsibilities
Strategic Leadership & Team Development
Provide oversight and leadership of a specialist sub-team within the CMC regulatory organization
Set clear expectations and performance objectives aligned with GRA goals
Foster an environment that promotes Taking the Lead behaviors and GRA Values
Global Regulatory Strategy Oversight
Oversee the development of global regulatory CMC strategies and risk assessments for development projects and marketed products
Ensure appropriate strategies for major CMC activities with critical regulatory and financial impact
Build and maintain internal/external relationships to achieve regulatory outcomes
Matrix Management Excellence
Enable effective matrix management between line organization and project Teams.
Establish clear roles and responsibilities between CMC Lead and Project Leads.
Coordinate with Project Leads on long-term resource planning
Regulatory Intelligence Leadership
Interpret global regulations and implement them within the team's work.
Identify and communicate regulatory paradigm shifts that impact the company.
Contribute knowledge to GRA Regulatory Science and Policy activities
Performance Management & Talent Development
Conduct regular performance evaluations and career development discussions
Identify skill gaps and create development opportunities through strategic project assignments
Work with Project Leads to identify and develop high-potential team members
Portfolio Management & Resource Optimization
Align team structure and capabilities with project portfolio needs.
Ensure balanced workload distribution among team members.
Collaborate with Project Leads to optimize resource allocation across projects
About You
Our Team
The Global Regulatory Affairs GRA CMC & Device Organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls CMC and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's Take the Lead values, particularly in Leading Together and Being Bold, mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.
Main responsibilities
Strategic Leadership & Team Development
Provide oversight and leadership of a specialist sub-team within the CMC regulatory organization
Set clear expectations and performance objectives aligned with GRA goals
Foster an environment that promotes Taking the Lead behaviors and GRA Values
Global Regulatory Strategy Oversight
Oversee the development of global regulatory CMC strategies and risk assessments for development projects and marketed products
Ensure appropriate strategies for major CMC activities with critical regulatory and financial impact
Build and maintain internal/external relationships to achieve regulatory outcomes
Matrix Management Excellence
Enable effective matrix management between line organization and project Teams.
Establish clear roles and responsibilities between CMC Lead and Project Leads.
Coordinate with Project Leads on long-term resource planning
Regulatory Intelligence Leadership
Interpret global regulations and implement them within the team's work.
Identify and communicate regulatory paradigm shifts that impact the company.
Contribute knowledge to GRA Regulatory Science and Policy activities
Performance Management & Talent Development
Conduct regular performance evaluations and career development discussions
Identify skill gaps and create development opportunities through strategic project assignments
Work with Project Leads to identify and develop high-potential team members
Portfolio Management & Resource Optimization
Align team structure and capabilities with project portfolio needs.
Ensure balanced workload distribution among team members.
Collaborate with Project Leads to optimize resource allocation across projects
About You
- Strong experience in pharmaceutical, CMC regulatory strategy experience, Expert-level understanding of CMC regulatory requirements across multiple regions
- Advanced knowledge of drug development, manufacturing, and testing processes, Strong understanding of AI and its applications in regulatory affairs, Exceptional leadership and team development abilities, Strategic thinking and ability to drive organizational change, Advanced negotiation and influencing skills with global regulatory bodies e.g., FDA, EMA. Ability to manage complex, multi-stakeholder relationships & Proven ability to make high-impact decisions in ambiguous situations
- Communication skills, Stakeholder management, Adaptability & flexibility, Critical thinking, Problem solving, Teamwork & collaboration, Time management, Emotional intelligence EQ, Compliance & quality mindset, Proactive ownership & Presentation skills
- Strategic Thinking, Results-Oriented, People Leadership, Influencing, Others Regulatory Strategies, Product Registrations, Risk Management, Digital Adoption, Stakeholder Management & Advanced proficiency in MS Office Suite & Electronic document management systems Veeva vault, Plai
Sourced from foundit
Skills
ms office suiteVeeva vaultInfluencing SkillsCMC regulatory strategyTesting processesElectronic document management systemsPlai
About Sanoh
Sanoh India
Auto Components
375
employees
1939
87 years old
Tokyo
Japan
₹4.4L PA avg
Avg at Sanoh
About
A manufacturer of automotive parts, specializing in tubing and other components, with a history of diversified production since 1939.
Industries
Auto ComponentsIndustrial MachineryManufacturing
Employee ratings
10 reviews
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Culture
4.0
Career growth
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Work-life
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