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Are you passionate about compliance, documentation, and global regulatory processes? A leading pharmaceutical company is hiring a Regulatory Affairs Associate in Hyderabad, Telangana, India. This site-dedicated role is a contract position (through a third-party vendor) and offers a chance to work in global operations, regulatory submissions, and cross-functional collaboration.
This position is ideal for candidates with a scientific background and a keen eye for detail who are looking to build their career in pharmaceutical regulatory affairs.
Key Responsibilities
As a Regulatory Affairs Associate, you will:
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- Coordinate preparation and delivery of global regulatory documents.
- Collaborate with Country Regulatory Managers (CRMs), global regulatory teams, and manufacturing units.
- Understand and implement local regulatory requirements.
- Manage project timelines, prioritization, and reporting using tracking tools.
- Archive documentation for compliance and traceability.
- Monitor requests to ensure timely processing and business alignment.
- Communicate project status updates to stakeholders.
- Proactively interact with SMEs, regulatory staff, and operations for document-specific requirements.
- Handle shifting priorities independently with strong organizational skills.
- Drive continuous process improvements within the team.
- Lead or support process improvement projects as needed.
Required Qualifications
- Bachelor’s degree in Information, Chemistry, Biology, or a related scientific discipline (or equivalent experience).
- Proficiency in MS Excel, Word, PowerPoint, SharePoint, and database tools.
- Strong organizational, project management, and communication skills.
- Previous regulatory or technical experience preferred.
- Experience in SAP EHS module is mandatory.
Benefits of Joining
- Opportunity to work on global regulatory submissions.
- Gain experience in a centralized regulatory operations environment.
- Collaborate with cross-functional teams across technical disciplines.
- Exposure to process improvements and project management in pharma operations.
- Competitive compensation package.
Application Process
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