Join a global leader in the life sciences and pharmaceutical industry, dedicated to improving patient outcomes through innovation and excellence. Our organization is committed to maintaining the highest standards of regulatory compliance and operational efficiency. With a strong presence in Hyderabad, we offer a dynamic work environment where professionals can grow and contribute to meaningful projects that impact lives worldwide.
Job Description
As a Regulatory Translation Coordinator, you will play a pivotal role in ensuring the integrity and compliance of our documentation systems. You will be responsible for maintaining controlled documentation, record retention, and information services in alignment with regulatory requirements. This position offers a unique opportunity to work closely with cross-functional teams and contribute to the success of our regulatory operations.
Key Responsibilities:
- Documentation Management:
- Ensure compliance with regulatory requirements for documentation and record retention.
- Maintain technical and non-technical documentation change systems.
- Classify and maintain records, ensuring proper procedures are in place.
- Interpret and enforce documentation formatting, standards, policies, and operating procedures.
- Administrative Support:
- Perform general coordination and administrative tasks to support the Regulatory Translation Hub.
- Manage access to repository folders and keep access information updated.
- Organize and archive documentation in team repositories.
- Renew licenses for translation-related software (e.g., Trados Studio, Verifika, dtSearch).
- Update team trackers, including job lists, invoicing, QC, and quality incidents.
- Assist in preparing reports and presentations.
- Operational Support:
- Assign urgent translation jobs to vendors and perform quick format checks on outsourced translations.
- Support file uploads and downloads from relevant databases.
- Invoice Management:
- Create Purchase Orders (POs) and manage invoices on behalf of the Head of Regulatory Translations.
- Maintain invoice records and address invoicing-related matters with vendors.
Skills and Qualifications
Required:
- Certified Administrative Professional (CAP) certification or equivalent administrative degree.
- Fluency in English (written and spoken). Proficiency in additional languages is a plus.
- Minimum 3 years of administrative experience, preferably in Regulatory Affairs.
- Strong problem-solving skills and proficiency in Microsoft Office tools (Excel is a must).
- Excellent organizational skills, adaptability, and commitment to quality.
- Good interpersonal skills and a team-oriented mindset.
Desired:
- Experience with Clinical Study Reports, Data Analysis, Documentation Management, and Regulatory Compliance.
- Knowledge of life sciences and operational excellence practices.
How to Apply
