Regulatory Affairs Associate

Job Overview:We are seeking a detail-oriented and motivated Regulatory Affairs Associate to assist in global regulatory submissions, ensuring compliance with applicable regulations and standards. The role requires coordination across multiple teams, with a focus on managing the regulatory lifecycle of pharmaceutical products. The ideal candidate will have experience in document preparation, project coordination, and knowledge of global regulatory standards, ensuring timely submission and maintenance of regulatory filings.Key Responsibilities:Regulatory Submissions:Assist in preparing global submissions, amendments, supplements, and annual reports (Product, DMF).Ensure all submissions comply with global regulations.Regulatory Strategy & Licensing:Aid in determining strategies for product changes.Assist with licensing activities such as Establishment Registration and state licensing updates.Project Coordination:Track and manage workflows for submissions.Collaborate with project teams to drive regulatory activities.Compliance & Reporting:Ensure compliance with cGMP regulations and support CARES Act reporting requirements.Support & Communication:Provide regulatory support to management and team members.Qualifications & Experience:Education: Bachelor’s degree in a scientific field (Chemistry or Pharmacy preferred) with 1-3 years of regulatory experience, or Master’s degree in Regulatory Affairs with at least 3 months of internship experience.Skills:Knowledge of global regulations and cGMP.Proficient in MS Office and document management systems.Strong organizational, communication, and teamwork skills.