Job Description
- Key Responsibilities:
- Ensure the submission and approval of high-quality regulatory applications within set timelines.
- Facilitate regular interactions with regulatory bodies for approvals.
- Collaborate with Asia-Pacific Trial Capabilities personnel to initiate investigator sites and monitor clinical trial regulations.
- Communicate country-specific regulatory and data privacy requirements to the team for incorporation into submission documents.
- Lead and participate in global clinical system projects.
- Serve as the local point of contact for trial capabilities-related activities.
- Coordinate the management and delivery of clinical trial material for site initiation.
- Ensure compliance with local regulations, quality system requirements, and good clinical practices (GCP).
Candidate Profile
- Required Qualifications:
- Bachelor’s degree, preferably in a scientific or health-related field.
- Minimum two years of clinical trial regulatory experience or relevant experience.
- Understanding of clinical development paradigms and efficient site activation.
- Familiarity with compliance-driven environments and project management processes.
- Effective communication, negotiation, and problem-solving skills.
- Self-management and organizational abilities.
- Fluency in English (both written and spoken), along with proficiency in the local language (if applicable).
Additional Information
- Location: Gurgaon, Haryana (preferred candidates located in or willing to relocate to the NCR region).
- Industry: Pharma, Healthcare, Clinical Research.
- Application Deadline: 10th December 2024.
This position offers a great opportunity for professionals with a background in clinical trial management and regulatory affairs to make a significant impact at a leading global healthcare organization.