Officer/Sr. Officer/ Executive-Regulatory Affairs (EU-US Market)

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Immacule

time outline icon Nalagarh, Himachal Pradesh, India

Posted on 14-03-2024

715 Views

1 Vacancy

Description

Coordinate and manage the preparation, compilation, and submission of regulatory dossiers, applications, variations, and other documentation for product registration in ROW markets, ensuring compliance with regulatory requirements, guidelines, and timelines.
Conduct regulatory intelligence and monitor changes in regulations, guidelines, and requirements in ROW markets, providing insights and recommendations to support regulatory strategies and decision-making.
Liaise with regulatory authorities, external consultants, distributors, and business partners in ROW markets to facilitate regulatory submissions, address queries, and obtain regulatory approvals and licenses.
Review and analyse regulatory documents, data, and submissions for accuracy, completeness, and compliance with regulatory standards and company policies, ensuring high-quality submissions and successful outcomes.
Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, Marketing, and Legal departments, to align regulatory strategies with business objectives, support product development activities, and ensure regulatory compliance throughout the product lifecycle.
Maintain regulatory databases, records, and documentation systems, ensuring documentation integrity, version control, and accessibility for audits, inspections, and reporting purposes.
Provide regulatory guidance, training, and support to internal stakeholders on regulatory requirements, processes, and best practices, fostering a culture of compliance and regulatory excellence within the organization.
Participate in regulatory meetings, project teams, and cross-functional initiatives, representing Regulatory Affairs and contributing expertise to achieve regulatory milestones and business goals.