Sr. Executive-Regulatory Affairs

4 - 8 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Suvenpharma

time outline icon Hyderabad, Telangana, India

Posted on 16-01-2024

689 Views

1 Vacancy

Description

Regulatory Compliance: Ensure compliance with applicable laws and regulations related to the industry, products, and geographical markets, staying updated on changes in regulatory requirements.
Documentation Preparation: Prepare, review, and submit regulatory documents, including applications, reports, and dossiers, to regulatory authorities for product approvals, registrations, and certifications.
Regulatory Strategy Development: Contribute to the development and execution of regulatory strategies, providing input on the submission process and timelines to facilitate efficient product approvals.
Communication with Regulatory Authorities: Establish and maintain effective communication with regulatory agencies, responding to inquiries, providing requested information, and representing the company during regulatory inspections or audits.
Labeling and Packaging Compliance: Ensure that product labeling and packaging comply with regulatory requirements, including the inclusion of necessary information, warnings, and adherence to specified formats.
Regulatory Intelligence: Stay informed about industry trends, changes in regulations, and competitive intelligence, providing insights to internal stakeholders to guide decision-making and strategy.
Quality System Compliance: Collaborate with quality assurance and other departments to ensure that quality management systems align with regulatory standards, and participate in the development and maintenance of such systems.
Training and Education: Provide training to internal teams on regulatory requirements, changes, and best practices, fostering a culture of compliance and awareness within the organization.