Job Title:
Regulatory Affairs Associate II – RIM (Regulatory Information Management)
Date Posted:
17 Sept 2025
Location:
Navi Mumbai, India, 400706
Company:
Teva Pharmaceuticals
Job ID:
64088
Company Overview:
Teva Pharmaceuticals is a global leader in generic and innovative medicines, committed to making healthcare more affordable and accessible. Teva operates across nearly 60 countries and produces many products listed on the WHO Essential Medicines List.
Role Overview:
The Regulatory Affairs (RA) Associate II in RIM supports the development, implementation, and maintenance of RA business systems and regulatory data to ensure compliance, quality, and efficiency across global operations. The role involves business analysis, project management, data administration, and collaboration with internal and external stakeholders.
Key Responsibilities:
RA Business Systems & Data Management:
Develop and implement RA business systems strategy to meet global and emerging business needs.
Provide expert business analysis for system roadmaps and project implementation.
Ensure compliant system usage and business change management for RA processes and data.
Manage Teva XEVMPD submissions for Investigational Medicinal Products and remediate Authorized Medicinal Product reports to ensure Article 57 compliance.
Support regulatory audits and inspections related to RIM/XEVMPD data.
Collaborate with the in-house Regulatory Data Administration team to maintain high-quality RA data for reporting and business decisions.
Project Management & Business Analysis:
Lead cross-regional and cross-functional project teams to enhance regulatory systems and processes.
Act as change manager and escalation point to ensure effective RA operations.
Map current and future business processes, integrating regulatory guidelines to ensure compliance.
Provide oversight of GRA data, including data quality decisions, system dictionary-controlled values, and work instructions.
Translate regulatory business requirements into strategic project proposals and deliver successful implementations.
Stakeholder Collaboration & Expertise:
Partner with internal Regulatory Affairs, IT, and strategy teams.
Engage with external pharmaceutical stakeholders and health authorities to influence outcomes (ISO IDMP, FMD).
Ensure alignment of regulatory data and systems with evolving regulatory requirements.
Communication & Reporting:
Communicate complex regulatory and project information effectively to all levels within the organization.
Provide analysis, guidance, and updates for ongoing RA business processes and technology initiatives.
Experience & Qualifications:
Education:
Required: Bachelor’s Degree in Life Sciences or Information Technology.
Preferred: Master’s Degree in a scientific or IT discipline.
Experience:
Required: 3–5 years in the pharmaceutical industry with direct experience in Regulatory Affairs.
Demonstrable experience leading cross-functional project teams within a multifunctional/geographical matrix.
Experience analyzing RA data requirements and managing regulatory data to maintain compliance.
Preferred: Extensive experience in Regulatory Affairs, cross-functional projects, and regulatory data management.
Experience with regulatory systems such as Parexel/Liquent Insight or Veeva RIM suite is advantageous.
Skills & Knowledge:
Knowledge of global regulatory requirements (FDA, EMA, Health Canada, Japan).
Understanding of global industry initiatives and regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP, SPOR).
Familiarity with RA business processes: regulatory submissions, CMC, product strategy, registration, and regulatory data management.
Understanding of drug development processes for generics, branded, and non-medical products is a plus.
Strong analytical, methodical, and communication skills to relay complex concepts clearly.
Reporting Line:
Reports to Sr Manager, RIM, Global Regulatory Operations
Equal Opportunity Statement:
Teva Pharmaceuticals provides equal employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations are provided to support candidates throughout the recruitment process.
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