MSc Biotech & Life Sciences Project Manager Job at Indivirtus Global, Apply on Biotecnika
Job Title: Project Manager (US FDA Submissions – Neurology/Alzheimer’s Focus)
Company: Indivirtus Global
Location: Bhubaneswar (with travel to US clinical sites as required)
Position Type: Full-time
Experience: 2–3 years (FDA Trials)
Salary Range: ₹6 LPA – ₹18 LPA (depending on experience)
About the Role
We are seeking an experienced Project Manager with a strong background in US FDA submissions for New Chemical Entities (NCEs), particularly in neurology and Alzheimer’s disease drug development. The ideal candidate will lead FDA submission processes, coordinate with sponsors and stakeholders, and oversee US clinical trial operations to ensure compliance and timely execution.
Key Responsibilities
• Lead and manage end-to-end FDA submission processes (IND/NDA) for NCEs in neurology/Alzheimer’s.
• Collaborate with sponsors to prepare, review, and coordinate regulatory documents for FDA filings.
• Oversee and monitor clinical trial sites in the US, ensuring compliance with GCP, FDA guidelines, and study protocols.
• Drive cross-functional project management across clinical, regulatory, medical, and operational teams.
• Serve as the central point of contact between sponsors, CROs, investigators, and regulatory authorities.
• Ensure projects are delivered on time, within scope, and compliant with regulatory expectations.
Qualifications & Skills
• Proven experience in FDA interactions and submission strategy (IND/NDA for NCEs).
• Background in clinical project management within neurological disorders/Alzheimer’s (preferred).
• Strong knowledge of ICH-GCP guidelines, clinical trial operations, and regulatory requirements.
• Excellent communication, leadership, and stakeholder management skills.
• Ability to work with global teams, with a focus on US clinical operations.
Education
• Master’s degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related field (required).
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