Executive FDA Licensing

Location: Borivli

Description   The Executive FDA Licensing role involves managing the licensing process with the FDA, ensuring that all regulatory requirements are met for our products and services in India. The successful candidate will play a crucial role in maintaining compliance and supporting our mission to deliver high-quality products to market.

Responsibilities    Conduct research and analysis on FDA regulations and licensing requirements.
Prepare and submit applications for FDA licensing on behalf of the organization.
Collaborate with cross-functional teams to ensure compliance with regulatory standards.
Monitor and interpret FDA updates and changes in regulations that may impact licensing processes.
Assist in the preparation of documentation for audits and inspections related to FDA licensing.

Skills and Qualifications    Bachelor's degree in Pharmacy, Life Sciences, or a related field.
1-4 years of experience in regulatory affairs, specifically with FDA licensing processes.
Strong understanding of FDA regulations and compliance requirements.
Excellent analytical and problem-solving skills.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Strong verbal and written communication skills.
Ability to work collaboratively in a team environment and manage multiple projects.