Duration
- 6 months or longer
Job Description
- Our Client is seeking a highly skilled and experienced Regulatory Clinical Trial Application Consultant for a contract role. The Regulatory Clinical Trial Application Consultant will play a critical role in supporting the preparation, submission, and management of clinical trial applications to ensure regulatory compliance and facilitate the smooth progression of clinical studies.
Responsibilities
- Clinical Trial Application Preparation: Lead and support the preparation of clinical trial applications (CTAs) and related documents, ensuring they meet regulatory requirements and guidelines.
- Submission Management: Coordinate and manage the submission process for clinical trial applications to health authorities and ethics committees. Track submission timelines, respond to regulatory queries, and ensure timely approvals.
- Regulatory Compliance: Ensure that all clinical trial activities adhere to applicable regulations and guidelines, including FDA, EMA, and ICH GCP standards. Monitor and update compliance practices as needed.
- Documentation Management: Maintain and organize regulatory documents related to clinical trials, including application files, correspondence with regulatory bodies, and compliance records.
- Regulatory Strategy: Provide strategic advice on regulatory requirements and processes for clinical trials, including guidance on regulatory pathways and submission strategies.
- Vendor Coordination: Work with external vendors and service providers to ensure compliance with regulatory standards and study protocols.
- Audit and Inspection Support: Assist with audit and inspection preparations by ensuring all regulatory documentation and processes are in order. Support responses to regulatory inspections and audits.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Experience: Minimum of 3 years of experience in regulatory affairs, specifically related to clinical trial applications and submissions, within the pharmaceutical or biotechnology industry.
- Knowledge: In-depth understanding of regulatory requirements for clinical trials, including FDA, EMA, and ICH GCP standards.
CH: Regulatory Clinical Trial Application Consultant (235701)
