GlaxoSmithKline is seeking a Regulatory Associate Manager for Product Variations in Bengaluru. This role involves managing CMC delivery and global regulatory dossiers for multiple Vx and Rx projects within a high-impact R&D environment.
Roles & Responsibilities:
Lead and execute dossier strategies for global regulatory submissions.
Manage multiple Rx and Vx project assignments simultaneously with varying complexity.
Perform data assessments to ensure dossiers are fit for purpose and compliant with regulations.
Act as a Subject Matter Expert (SME) and mentor for new team members.
Coordinate with Pharma Supply Chain (PSC), Quality Assurance, and 3rd Party CMOs.
Identify risks in submission packages and escalate issues with potential business impact.
Requirements:
Bachelor's degree in Pharmacy, Chemistry, or a related technical science field.
Minimum 3 to 8 years of experience in the pharmaceutical industry or R&D processes.
Strong knowledge of Global/EMAP Regulatory submission requirements and agency guidelines.
Ability to work effectively in a matrix environment with global stakeholders.
Proven organizational skills and attention to detail under tight regulatory deadlines.
Perks & Benefits:
Comprehensive health insurance coverage.
Opportunity to work at a leading global biopharma company.
Supportive culture focused on inclusion and professional growth.
Access to cutting-edge technology and world-class R&D resources.
Additional Information:
Work Arrangement: On-site in Bengaluru with virtual collaboration with global teams.
Equal opportunity employer committed to diversity and inclusion.
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