Senior Specialist, RA Operations
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Job Summary
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 companys 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:
Bachelors 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:
- 58 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.
Required Experience:
Senior IC
About Company
Improve lives with a career at Fresenius Medical Care. Join a global leader in dialysis care and innovative health solutions.
