Available Openings 1
Position Specific Information
This position can be remote
Senior Regulatory Operations Associate:
- In 2020 the regulatory operations team has processed approximately 100+ drug submissions. In 2021 with the increased projects, we are projecting an additional 50+ submissions.
- The regulatory operation roles consist of but not limited to the following:
- In house formatting/publishing/submissions to support all drug applications to the FDA, see list of projects above
- Manage/maintain all publishing/archiving tools. (RimSmart/ISI toolbox etc.)
- System Upgrade, validations / UAT testing, Document Management (Archiving submissions and Correspondence),
- In house generation of FDA system-compliant structured product labeling (SPL) to support establishment registration and product listing
- Support growing number of Pharma submissions over the upcoming years
- Take lead on Word Template and ARIM training for stakeholders who directly are involved authoring the content of the application
- Responsible for archiving of all drug submissions
- Provide mentorship to low level associates
- Responsible for daily management of all submission to ensure on time completion
PURPOSE AND SCOPE:
Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and device products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- A seasoned, experienced professional with a full understanding of Regulatory Affairs; resolves a wide range of issues in creative ways.
- Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with regional requirements and company standards.
- Works closely with contributing functional departments to ensure understanding of requirements and handoff of submission components in the appropriate format.
- Prepares interpretative analyses of key regulatory guidance documents related to submissions. Interprets local electronic submissions regulations.
- Assists in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.
- Compiles, publishes, QC, and validates documents for FDA submission.
- Troubleshoots document issues in MS Word and Adobe Acrobat.
- Works with department and external groups as assigned.
- Evaluates and provides input for new department technologies and collaborates with intra-departmental resources to ensure adherence to infrastructure standards.
- Participates in the development of standards and processes in support of efficient submission development, review, approval and archival.
- Supports the transition from legacy to electronic submissions.
- Coordinates with regulatory staff to compile regulatory submissions.
- Ensures that all required documents are received and formatted appropriately and in a timely manner.
- Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements.
- Aligns document access and storage with RA electronic submission needs.
- May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
- May escalate issues to supervisor/manager for resolution, as deemed necessary.
- Mentor other staff as applicable.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Assist with various projects as assigned by a direct supervisor.
- Other duties as assigned.
Additional responsibilities may include 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 are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
- 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.
- Prior experience with electronic document management systems required.
- Strong understanding of document management processes in a regulated pharmaceutical/device environment.
- Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher).
- Knowledge of EDM, RIM and electronic publishing software preferred. Experience with electronic submissions, specifically eCTD, or eCopy a plus.
- Demonstrated understanding of the drug development process and project management experience is highly preferred.
- Outstanding interpersonal and communication (written and verbal) skills.
- Strong software troubleshooting skills highly desirable.
- Detail oriented; ability to work under deadlines; strong organizational skills required
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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