Associate I, Regulatory Operations
Alcon · Bengaluru · onsite · Posted 51d ago
Undisclosed3–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us
This role is part of Alcons Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.
This role is part of Alcons Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.
This Associate I, Regulatory Operations (State Licensing) is primarily responsible for supporting U.S. state licensing activities by assisting with regulatory filings, maintaining licensing databases and records, monitoring deadlines, and supporting compliance with applicable federal and state requirements. This role supports the preparation and submission of licensing applications, renewals, amendments, and related filings, while maintaining State Licensing archives and documentation.
Specifics Include:
- Apply specialized knowledge to support activities associated with U.S. state regulatory agencies and licensing requirements.
- Perform routine administrative activities, including data entry, record maintenance, document preparation, and filing support within State Licensing systems and databases.
- Support the preparation and submission of applications, renewals, amendments, discontinuations, and other state regulatory filings.
- Collect, organize, maintain, and distribute licensing records, state license certificates, submission documentation, and approval records within the State Licensing databases, archives, and tracking systems.
- Monitor licensing deadlines, regulatory requirements, and submission statuses to support timely and compliant filings.
- Partner with Regulatory Affairs, Legal, Quality, Supply Chain, Commercial Operations, and other cross-functional stakeholders to obtain information necessary to support licensing activities.
- Research regulatory requirements and support internal communications regarding potential business impacts.
- Support established processes to help maintain compliance with applicable federal and state regulations, including DSCSA, PDMA, FDCA, and state licensing requirements across all 51 U.S. jurisdictions.
- Identify and support opportunities to improve licensing processes, operational efficiency, data quality, and compliance systems.
- Demonstrate strong attention to detail, accountability, and reliability while executing assigned responsibilities.
- Adhere to applicable Good Practice (GxP) regulations and company standards by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and completing all required training.
- Meet individual performance expectations while contributing to the overall compliance objectives of the organization.
All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations .
Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.
Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
data qualityContinuous improvementManager Quality ControlMonitoringStandard Operating ProceduresLicensingSupply ChainoperationsAdministrationRecruitment
About Alcon
Alcon
Medical Equipment
2.2k+
employees
1945
81 years old
Fort Worth,Texas
United States
About
A global leader in eye care, offering innovative surgical and vision care products while prioritizing research and development to meet evolving patient needs.
Industries
Medical EquipmentInternetAnalytics & KPO
Employee ratings
581 reviews
3.8/ 5
Culture
3.7
Career growth
3.0
Work-life
3.8
Employees rate it well for
Work Life Balance71Work Culture67Senior Management50Salary48Job Security36
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