Regulatory Affairs Director

4 days ago

Serilingampalle M, India Lifelancer Full time
About the Role

We are seeking an experienced Senior Regulatory Affairs Director to join our team at Lifelancer. In this role, you will be responsible for leading clinical trial regulatory submissions and providing strategic guidance on regulatory matters.

Key Responsibilities:
  • Clinical Trial Regulatory Submissions: With over 15 years of relevant experience, you will lead clinical trial regulatory submissions and ensure compliance with regulatory requirements.
  • Regulatory Leadership: As a seasoned Regulatory Lead, you will manage global trials and provide regulatory expertise in the European market.
  • Database Expertise: Proficiency in handling the CTIS database and submitting EU CTR and CDSCO is highly desirable.
  • Project Profitability: You will monitor project profitability and collaborate with project leads to prepare project plans and manage project budgets.
  • Revenue Recognition: Proactively identify and resolve issues related to revenue recognition.
Requirements:
  • Experience: Over 15 years of experience in clinical trial regulatory submissions.
  • Skillset: Strong knowledge of regulatory requirements, database management, and project management.
What We Offer:
  • Competitive Salary: An estimated annual salary of $120,000 - $180,000 based on location and experience.
  • Benefits: Comprehensive benefits package including health insurance, retirement plan, and paid time off.
  • Professional Growth: Opportunities for professional growth and development in a dynamic and innovative company.