Senior Global Regulatory Scientist
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Job Description
Global Regulatory Scientist leading pharmaceutical clinical-trial regulatory submissions for ICON, a global healthcare intelligence and clinical research organisation. Office or home-based in India.
Responsibilities:
- Ensure regulatory deliverables comply with relevant regulations, guidelines, policies and procedures within contractual timelines and budget.
- Develop overall and global clinical trial submission strategies with stakeholders, including risk identification and mitigation.
- Lead assigned clinical trial Regulatory project teams.
- Serve as client point of contact for clinical trial Regulatory deliverables.
- Prepare clinical trial Regulatory plans according to project specifications.
- Prepare, create, adapt, coordinate, collate and ensure compliance of global core documents.
- Track and report submission and approval progress in CTMS, eTMF and other applicable systems.
- Perform quality control reviews of clinical trial Regulatory deliverables.
- Coordinate submissions to regulatory agencies, central ethics committees and country-level authorities.
- Coordinate clinical trial label review and approval.
- Manage Regulatory study budgets and identify out-of-scope activities.
- Support maintenance of current Country and Regulatory Intelligence.
- Provide Regulatory consulting services as needed.
- Participate in business or organizational development activities.
- Mentor junior team members as needed.
Requirements:
- BSc degree in a scientific field.
- 3-6 years’ relevant global regulatory experience in clinical trials for pharmaceuticals.
- Good communications and client-facing skills.
- Adaptive personality with an agile mindset.
- Fluent English.
- Legal right to work in the country where the role is based.
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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