Work from anywhere and shape powerful strategies that drive results! Enjoy the freedom of remote work while making a global impact with this position in Regulatory Operations.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking a Regulatory Operations Consultant to oversee the preparation, publishing, and delivery of electronic regulatory submissions to global health authorities. This role focuses on ensuring compliance with technical, regulatory, and procedural requirements to support marketing authorizations, clinical trial applications, and lifecycle management activities across various markets.
Responsibilities:
- Lead the assembly, publishing, and quality control of electronic submissions (eCTD and NeeS) in line with regional authority requirements.
- Plan and manage submission timelines to ensure timely delivery to health authorities, coordinating with global regulatory teams.
- Ensure technical compliance through proper document formatting, hyperlinking, bookmarking, and metadata accuracy.
- Manage electronic submission gateways and portals, including FDA ESG, EMA CESP, MHRA Submissions Portal, and ANVISA systems.
- Act as the primary operational contact for submission publishing, addressing technical and formatting issues.
- Conduct pre-publishing assessments to ensure submission readiness and consistency across modules.
- Perform final validation and lifecycle maintenance of submissions, ensuring correct sequence management and submission integrity.
- Stay updated on ICH and regional eCTD specifications, implementing changes in publishing practices as needed.
- Collaborate with cross-functional teams to define submission structure, content placement, and publishing strategy.
- Maintain internal submission tracking systems, ensure complete and compliant submission archives, and support audits or inspections.
Key Skills and Requirements:
- Bachelor's degree in life sciences, information management, or a related field; advanced degree preferred.
- Expertise in regulatory operations, particularly eCTD publishing and global submission delivery.
- Proficiency in compiling and submitting regulatory dossiers to EMA, FDA, MHRA, and ANVISA.
- Familiarity with submission publishing tools such as Veeva, Lorenz docuBridge, EXTEDO eCTDmanager, or similar systems.
- Strong understanding of regional publishing requirements and sequence lifecycle management.
- Exceptional attention to detail, organizational skills, and problem-solving abilities.
- Effective communication and teamwork skills in global and cross-functional environments.
- Fluency in written and spoken English; additional language proficiency (e.g., Portuguese, Spanish) is a plus.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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