Position Title: Regulatory to Operations (R2O) & Safety Data Sheet (SDS) Country Lead
Job Type: Long-term contractual position with a six-month renewal cycle.
Experience: 3-5 Years
Job Location: Hyderabad
Shift Timings: 12 PM to 9 PM IST
Job Description
The Regulatory to Operations (R2O) & Safety Data Sheet (SDS) Country Lead is accountable for supporting the Regulatory and Stewardship team ensure efficient management of regulatory data and generation/compilation of compliant documents required for various regulatory/business needs. This role requires cross functional interaction with teams across multiple technical disciplines. Candidates should be results oriented and organized with a proven ability to work effectively within a centralized team environment as well as independently.
Responsibilities
- Coordinates global regulatory document preparation and delivery working closely with Country Regulatory Managers (CRMs), Subject Matter Experts, Manufacturing, and Global Regulatory Teams.
- Works closely with CRMs to understand the local requirements of the document requests.
- Utilizes the tracking tool for metrics.
- Executes the delivery of documents to the CRMs and archives a copy of the documentation for future reference and traceability.
- Monitors requests to ensure follow up and processing is completed in a timely fashion to meet business requirements.
- Ensures communication of project status to key stakeholders.
- Proactively reaches out to appropriate subject matter experts, global, regional or country regulatory staff, or operations as needed to understand and implement specific requirements for document requests.
- Independently manages shifting priorities based on requests and document timelines.
- Participates in team meetings and effectively communicates with global regulatory and business staff.
- Champions continuous improvement within the team.
- Leads and/or participates in other projects or process improvement efforts as needed.
- Develops and writes comprehensive SDSs for chemical products. Ensures that SDSs are accurate, complete, and compliant with relevant regulations and standards.
- Stays informed about global and regional regulations related to chemical safety and SDS requirements.
- Gathers and analyzes data from various sources, including scientific literature, test reports, and supplier information. Ensure the accuracy and reliability of the data used in SDS preparation.
- Maintains accurate records of all SDSs and related documentation.
- Ensures that SDSs are easily accessible to employees, customers, and regulatory authorities.
- Provides guidance and support to internal teams and external stakeholders on SDS-related issues.
- Regularly updates SDSs to reflect new information, regulatory changes, or product modifications.
Qualifications
Minimum BA degree. Preferred of a BS degree in information, chemistry, biology or related scientific field (or equivalent experience).
Proficient using MS Excel, Word, PowerPoint, and SharePoint as well as familiarity with database environments.
Excellent project management, organization, written and oral communication skills.
Previous technical or regulatory experience desired.
