Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Regulatory Data Coordinator managing activities within V-RIM process in Colombia. Leading complex projects and ensuring data accuracy in regulatory submissions.
Responsibilities
- Develops ideas and leads/co-leads complex projects across RIO, G&IPE & GRS.
- Develops and manages plans to achieve objectives
- Applies skills and discipline knowledge to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit
- Makes decisions that require developing innovative options to resolve complex problems
- Leads operational team(s) within and across Work Teams and Departments
- Management of all related RIM events and their related records
- Interpret communications and drive appropriate actions to update system
- Evaluate and approve data change requests
- Ensuring maintenance across the lifecycle
- Train & support business users on data quality standards and data & process management best practices.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
- 6+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.
- Significant experience with master data management and data quality improvement.
Benefits
- EEO (Equal Employment Opportunity) & Employment Eligibility
- Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Tech Compliance Analyst at Syneos Health responsible for global Technology Disaster Recovery efforts, collaborating with various teams and service providers.
BL
Chief Nuclear Officer serving as the nuclear safety authority for BaRupOn's SMR/MMR programs. Establishing safety frameworks and ensuring regulatory compliance within the organization.
International Trade Compliance Manager overseeing compliance with international trade regulations at Northrop Grumman. Leading a team and managing compliance initiatives across multiple locations in the US.
Compliance Manager leading Autodesk's Enterprise Compliance program. Ensuring compliance with SOX, PCI regulations and overseeing security controls across teams.
Compliance Student supporting compliance and risk management activities for individual insurance at iA Financial Group. Involves monitoring processes, collaborating with teams, and assisting with compliance tasks.
Nurse Licensure & Compliance Coordinator managing multi - state nurse licensure and compliance inquiries while ensuring a positive nurse experience. Advocating for nurses and maintaining regulatory adherence at the organization.
508 Compliance Specialist working with the Office of the Inspector General for the DoD. Responsible for ensuring electronic accessibility for compliance with Section 508 regulations.
Senior Manager in Regulatory Affairs overseeing submission management and regulatory compliance. Leading cross - functional teams in a neuroscience - focused biopharmaceutical environment.
Local Compliance & Ethics Officer at Teva Germany serving local management and compliance program. Leading compliance initiatives and collaborating with various stakeholders while managing risks and providing guidance.