JOB TITLE:
Senior Regulatory Affairs Associate, Global eCTD Operations
EXEMPTION STATUS:
Exempt
POSITION LEVEL:
JOB CODE:
JOB GRADE:
JOB FAMILY:
SA-Regulatory Affairs
VERSION:
PURPOSE AND SCOPE:
The Senior Regulatory Affairs (RA) Associate, Operations, plays a critical role in the planning, preparation, and management of global electronic Common Technical Document (eCTD) submissions that support the approval and maintenance of licensed pharmaceutical products worldwide.
This position ensures full compliance with global electronic submission requirements, including those of the U.S. FDA, EMA, China NMPA, Health Canada, LATAM, and other regulatory authorities and contributes to continuous improvement of global submission standards, systems, and processes within the Regulatory Affairs Operations function..
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Serve as a subject matter expert (SME) in global eCTD publishing and submission management, ensuring compliance with regional regulations and technical requirements (U.S., EU, China, APAC, LATAM).
Lead the preparation, compilation, quality check, validation, and delivery of high-quality global regulatory submissions using eCTD and related formats.
Collaborate cross-functionally with Global and Local Regulatory Affairs teams to ensure timely, accurate handoff and harmonization of submission components across regions.
Apply deep understanding of global eCTD structure, lifecycle management, and validation standards to troubleshoot and resolve technical issues.
Interpret and implement evolving global eCTD and electronic submission guidance, proactively ensuring readiness for new regulatory initiatives and format updates.
Develop, maintain, and enhance departmental templates, standards, and workflows for electronic submissions and regulatory information systems.
Manage submission content in accordance with company policies, ensuring data integrity, version control, and compliance across all submission types (IND/CTA, NDA/MAA, DMF, lifecycle updates, PSURs, etc.).
Partner with internal IT and publishing teams to optimize global systems, technologies, and submission infrastructure (e.g., Veeva, RIMSmart).
Provide mentorship and training to junior publishing or RA Operations staff, fostering consistency and global best practices in eCTD publishing.
Uphold the company’s Code of Business Conduct and all applicable regulatory, state, and federal compliance standards.
Participate in cross-functional initiatives and special projects to advance global regulatory operations efficiency and compliance.
Additional responsibilities may include a focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS
:
The physical demands and work environment characteristics described here represent those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION
:
Bachelor’s degree in a scientific, technical, or related discipline required (e.g., Life Sciences, Pharmacy, Chemistry).
Advanced degree preferred.
An equivalent combination of education and relevant regulatory experience may be considered.
EXPERIENCE AND REQUIRED SKILLS
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5–8 years of hands-on experience with global eCTD publishing, submission lifecycle management, and regulatory operations.
Proven experience preparing, compiling, and submitting complex global eCTD sequences for multiple markets (U.S., EU, China, LATAM, APAC).
Demonstrated mastery of eCTD structure, lifecycle sequences, validation criteria, and submission portal requirements, including Gateway, CESP, and BfArM.
Proficiency with regulatory information and document management systems, particularly Veeva Vault RIM and RIMSmart; experience with eCTD validation and publishing tools required.
Strong technical skills in MS Word, Adobe Acrobat, and other authoring/publishing software with advanced troubleshooting capabilities.
Deep understanding of the global drug development process and the regulatory frameworks governing electronic submissions.
Exceptional attention to detail, organizational discipline, and ability to manage multiple global submissions under tight deadlines.
Excellent written and verbal communication skills with the ability to convey complex technical and regulatory information clearly.
Collaborative team player who thrives in a fast-paced, cross-functional global environment and demonstrates strong problem-solving and project management skills.
