Regulatory Affairs Specialist – CMC (Small Molecules)
Location: Bengaluru, Karnataka, India
Job Type: Full-Time | Hybrid (On-site presence required)
Experience Required: 3–6 Years
Job Reference ID: 25-PJT00436M
Domain: Regulatory Affairs | CMC | Small Molecules
Job Overview
A leading global pharmaceutical organization is seeking a Regulatory Affairs Specialist – CMC (Small Molecules) to support Chemistry, Manufacturing, and Controls (CMC) regulatory activities across development and commercial product lifecycles. Based at the Global Capability Center (GCC) in Bengaluru, this role plays a key part in ensuring high-quality, compliant CMC submissions aligned with global regulatory expectations.
The position is ideal for regulatory professionals with hands-on experience in CMC regulatory submissions, small molecule development, and global health authority interactions, looking to contribute to innovative science and patient-focused outcomes.
Key Responsibilities
Support preparation, compilation, and submission of CMC regulatory documents in accordance with global regulations, internal SOPs, and defined timelines
Contribute to regulatory impact assessments for proposed CMC changes and monitor their progress through regulatory pathways
Author, review, and manage CMC documentation, ensuring accurate version control, metadata, and dossier integrity
Support assigned products across development and post-approval phases, including IND/CTA, original MAA/BLA filings, variations, and responses to health authority questions
Act as a CMC Regulatory Affairs Deputy, supporting Scientific Leads for development programs and marketed products
Identify, communicate, and escalate potential regulatory risks or issues in a timely manner
Contribute to interpretation, archiving, and knowledge sharing of global CMC regulatory requirements
Collaborate cross-functionally with Global Regulatory Affairs, Quality Assurance, Product Development, and Manufacturing teams
Ensure continuous compliance with applicable regulations, guidelines, and internal training requirements
Execute assignments with a strong focus on accuracy, efficiency, innovation, and regulatory compliance
Education and Experience Requirements
Bachelor’s degree (minimum) in Chemistry, Pharmacy, Chemical Engineering, Biology, Biochemistry, Microbiology, or a related scientific discipline
Graduate degree in a relevant field is preferred
Minimum 3 years of experience in CMC Regulatory Affairs, pharmaceutical manufacturing, biological/vaccine research, testing, or related regulatory functions
Candidates with a graduate degree may be considered with 1+ year of relevant experience
Required Skills and Competencies
Strong ability to critically review scientific and technical data and assess regulatory adequacy
Working knowledge of global CMC regulatory requirements and guidelines
Excellent organizational skills with the ability to integrate information from multiple systems
Proficiency in English (written and verbal); additional languages are an advantage
Ability to manage multiple projects with overlapping timelines in a fast-paced environment
Strong stakeholder communication and collaboration skills
Preferred Qualifications
Prior experience supporting small molecule CMC programs
Hands-on experience with CMC regulatory or quality systems such as Veeva Vault, TrackWise Digital, or similar platforms
Knowledge of FDA, EMA, ICH, and other global regulatory frameworks, with the ability to interpret and communicate regulatory expectations
Organizational Context
Reports to Director or Senior Director, Regulatory Affairs CMC
Provides regulatory support across multiple projects and modalities
Works collaboratively across the CMC Regulatory Affairs organization and cross-functional teams
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 support innovation across the pharmaceutical value chain. These centers are integral to delivering sustainable growth and transforming scientific innovation into value for patients worldwide.
Important Notice
Applicants are advised to be cautious of recruitment scams. All official communications will originate from verified company email addresses or authorized professional profiles.
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