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Regulatory Operations
4 months ago
This is an excellent opportunity for an experienced Regulatory Professional with knowledge of Clinical Trials Regulation and CTIS to join a top global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and growth.
The following information provides an overview of the skills, qualities, and qualifications needed for this role.
Responsibilities:
- Oversee a portfolio of CTAs, managing the preparation and dissemination of documentation for new initial CTAs and all CTA maintenance activities, including substantial amendments and end-of-trial notifications.
- Offer guidance on submission strategy, country-specific requirements, and operational assistance for Regulatory submission preparation and processing of amendments.
- Ensure adherence to approved company CTA processes within established timelines.
- Demonstrate a thorough understanding of the Clinical Trial Regulation (CTR) process and its requirements.
- Track key project milestones, compare actual progress with planned activities and timelines, and communicate any issues or changes to relevant stakeholders and management in accordance with company procedures.
- Populate relevant databases and activity trackers within agreed timelines, ensuring compliance with reporting requirements, and provide operational support for Regulatory and/or non-Regulatory systems critical for Regulatory submission and maintenance activities.
About You:
- Regulatory operations experience with global clinical trial submissions to regulatory agencies. Specifically with CTIS portal Knowledge,
- Demonstrated ability to work effectively across diverse cultures and within complex matrix environments.
- Proficient in Information Technology, including MS Word, Excel, PowerPoint, Adobe Acrobat, and global databases.
- Proactive communication style, both written and verbal, with a solution-driven approach.
- Exhibits high levels of initiative and independence, along with strong interpersonal skills and the ability to establish and maintain working relationships across remote geographical locations.
If you're interested in the above role then please click apply or get in touch to discuss further.
Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.
