Regulatory Compliance Specialist II

3 days ago


Mumbai, Maharashtra, India Lifelancer Full time
Job Summary
We are seeking a motivated and detail-oriented individual to join our team as a Site Readiness and Reg Specialist II. In this role, you will be responsible for ensuring compliance with regulatory requirements and supporting the successful execution of clinical trials.

Key Responsibilities
• Develop and maintain knowledge of regulatory legislation, guidance, and practice in assigned regions and countries
• Complete activities for clinical trial applications according to the European Clinical Trials Regulation No 536 2014 in CTIS
• Collaborate with colleagues to ensure timely completion of tasks and accurate data entry
• Identify and escalate potential issues or concerns related to regulatory compliance

Requirements
• Bachelor's degree in a life science or related field
• Minimum 2 years of experience in regulatory affairs or a related field
• Strong analytical and problem-solving skills
• Ability to work effectively in a team environment and adapt to changing priorities

What We Offer
Lifelancer offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We also provide opportunities for professional growth and development through training and mentorship programs.

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