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Unit Management:
- Coordinate day-to-day delivery of regulatory services, including compilation of filings and submissions.
- Conduct regulatory and safety reviews, create educational tools, and stay current on regulatory requirements.
Client Services:
- Provide regulatory, ethics, and pharmacovigilance guidance to project stakeholders.
- Represent the unit at project meetings, audits, and with regulatory authorities.
Regulatory Strategy Development:
- Identify changes in clinical research regulations and recommend corporate strategies.
- Collaborate with experts in safety and quality assurance to meet compliance requirements.
Project Support:
- Respond to registration requests and assist in preparation of regulatory submissions.
- Ensure project files are maintained and stakeholders are informed on regulatory requirements.
Alimentiv
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.