Regulatory Affairs Officer

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Renova Lifesciences

time outline icon Rajkot, Gujarat, India

Posted on 07-10-2024

175 Views

1 Vacancy

Description

Regulatory Compliance: Ensure compliance with relevant local, national, and international regulations governing the development, manufacturing, and marketing of products, particularly in the pharmaceutical, medical device, or biotechnology sectors.
Submission Preparation: Prepare and submit regulatory documents, including product registration applications, variations, and renewals, ensuring timely and accurate submission to regulatory agencies.
Regulatory Strategy Development: Develop and implement regulatory strategies to support product development and approval processes, aligning with business goals and market entry plans.
Collaboration with Teams: Work closely with cross-functional teams, including research and development, quality assurance, and marketing, to ensure compliance throughout the product lifecycle.
Regulatory Intelligence: Stay informed about changes in regulatory policies, guidelines, and industry trends, providing insights and recommendations to management regarding potential impacts on the organization.
Communication with Regulatory Authorities: Serve as the primary point of contact with regulatory agencies, addressing inquiries, responding to feedback, and facilitating communication during the review process.
Risk Assessment: Assess regulatory risks associated with product development and marketing strategies, recommending mitigation plans to ensure compliance and successful product launches.
Training and Development: Provide training and guidance to internal teams on regulatory requirements and best practices, fostering a culture of compliance within the organization.