Regulatory Affairs Associate - Operations Coordinator

Biopharma Careers; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sandoz is seeking an experienced Regulatory Affairs admin professional in India to support the Regulatory Affairs team with regulatory systems, databases and documentation to ensure compliance and data integrity.

The role includes inbox management, meeting coordination, training support, event administration and stakeholder engagement to ensure regulatory activities are executed accurately and efficiently in line with internal procedures and health authority requirements.

Qualifications

• Experience in regulatory affairs support or similar role.
• Familiarity with regulatory information management systems.

Responsibilities

• Assist the Director of Scientific Affairs with meetings, activities, reports, newsletters and projects as required.
• Monitor and disseminate group inbox for regulatory correspondence.
• Manage health authority portal access and other system administration.
• Ensure timely processing and payment of invoices for Regulatory Affairs, including raising POs and new vendor requests and reconciling regulatory spend with BPA.
• Create, process, and manage purchase orders for external vendors and service providers.
• Ensure timely reconciliation of department purchasing card statements.
• Oversee end-to-end RLD sample procurement activities with global vendors and external partners.
• Oversee regulatory records management and assist with off-site archiving requests.
• Accountable for accurate entries into local and global databases and tracking platforms for RIM and ANZ submissions.
• Assist in review and maintenance of local WPs and SOPs to refine processes.
• Assist in developing dossiers and submissions to meet HA requirements.

Skills

Regulatory affairs

Documentation management

Stakeholder management

Tools

RIM databases

Invoice reconciliation systems

Job description

## About this opportunity**Job Description Summary**Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!Provide effective operational and administrative support to the Regulatory Affairs team by maintain-ing regulatory systems, databases and documentation to ensure compliance, data integrity and effi-cient business operations.Support the team through inbox management, meeting coordination, training support, eventadministration, and stakeholder engagement to ensure regulatory activities are executed accurately,efficiently, and in accordance with internal procedures and health authority requirements.**Job Description****Your Key Responsibilities:**Your responsibilities include, but not limited to:**1. Internal Stakeholder Relationships**Assist the Director of Scientific Affairs with meetings, activities, reports, newsletters and projects as required. Monitor and disseminate group inbox for regulatory correspondence.Manage health authority portal access and other system administration. Ensure timely processing and payment of invoices for Regulatory Affairs, including raising POs and new vendor requests and reconciling regulatory spend with BPACreate, process, and manage purchase orders for external vendors and service providers, incl invoice reconciliation, and compliance with company procurement and financial procedures. Ensure timely reconciliation of department purchasing card statements for Regulatory Affairs departmentOversee end-to-end RLD sample procurement activities, coordinating orders and deliveries with global vendors and external partners. Oversee regulatory records management, including maintaining departmental archiving records and assist team members with requests to send or recall items from off-site archivingAccountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitmentsAssist in the review and maintenance of local WPs and SOPs to refine processes and procedures in accordance with global SOPs. Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.