Regulatory Affairs Lead – CMC Biologics
Location: Bengaluru, Karnataka, India
Job Type: Full-Time | Hybrid (On-site presence required)
Experience Required: 8–12 Years
Job Reference ID: 25-PJT00250M
Function: Regulatory Affairs | CMC | Biologics
Job Overview
A global pharmaceutical organization is seeking a Regulatory Affairs Lead – CMC Biologics to provide strategic leadership for Chemistry, Manufacturing, and Controls (CMC) regulatory activities across development and commercial biologics portfolios. Based at the Global Capability Center (GCC) in Bengaluru, this role plays a critical part in shaping global CMC regulatory strategies, leading complex submissions, and supporting global health authority interactions.
This position is well suited for senior regulatory professionals with deep expertise in biologics CMC, global regulatory frameworks, and cross-functional leadership, who are ready to influence regulatory strategy at a global level.
Key Responsibilities
Serve as the global CMC Regulatory Affairs Lead or Deputy for complex biologics programs and cross-portfolio initiatives
Define and drive global CMC regulatory strategies for new molecular entities (NMEs), new biologic entities (NBEs), and lifecycle management activities
Provide expert regulatory guidance to global project teams and task forces, ensuring alignment with FDA, EMA, ICH, and other global regulatory requirements
Lead preparation, review, and approval of complex global regulatory submissions, including original registrations, variations, supplements, and responses to health authority queries
Oversee compilation, quality review, and timely submission of global regulatory dossiers, including detailed oversight of eCTD Module 3 content
Collaborate closely with Pharmaceutical Technology, Quality Assurance, Manufacturing, and Global Regulatory Affairs teams to resolve complex CMC issues
Support health authority meetings, regulatory negotiations, and inspection readiness related to CMC matters
Provide regulatory leadership for compendial strategy, including JP, EP, USP, and national monographs
Contribute to global regulatory and therapeutic area strategy development, ensuring alignment with corporate objectives
Mentor team members and, where applicable, manage or support direct reports
Education and Experience Requirements
Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline (required)
Advanced degree (MS, PhD, PharmD, or equivalent) is preferred
Minimum 10 years of pharmaceutical industry experience, with at least 6 years in Regulatory Affairs or CMC regulatory roles
Demonstrated experience managing global CMC regulatory activities for biologics across multiple dosage forms
Hands-on experience with biologic drug substance and drug product development, including process development, analytical characterization, scale-up, and registration
Proven track record of successful interactions with global health authorities on CMC matters
Required Skills and Competencies
Expert knowledge of EU, US, Japan, and global regulatory requirements for biologics across the product lifecycle
Strong strategic thinking and independent decision-making capability for complex regulatory scenarios
Advanced written and verbal communication skills with the ability to influence global stakeholders
Ability to operate effectively in a matrixed, cross-functional, and international environment
High attention to quality, compliance, and regulatory risk management
Fluency in English (spoken and written)
Preferred Qualifications
Experience managing or mentoring direct reports
Exposure to advanced biologics such as monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), vaccines, cell and gene therapies, or combination products
Experience supporting licensing due diligence and global business development activities
Organizational Context
Reports to Director or Senior Director, Regulatory Affairs CMC
Acts as a global subject matter expert across biologics CMC
Supports multiple high-impact programs with overlapping timelines
About the Global Capability Centers (GCCs)
The organization’s Global Capability Centers in India, Poland, and Mexico enable access to global talent, enhance operational efficiency, and strengthen innovation across the pharmaceutical value chain. GCCs play a vital role in supporting global regulatory excellence and transforming scientific innovation into value for patients worldwide.
Important Notice
Candidates are advised to remain vigilant against recruitment scams. All official recruitment communications will originate from verified company email addresses or authorized professional profiles only.
Apply now on thepharmadaily.com to advance your leadership career in CMC Regulatory Affairs for Biologics and contribute to globally impactful pharmaceutical programs.
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