Regulatory Operations Associate
Summary of Position:
Reporting directly to the Regulatory Operations Manager, the Regulatory Operations Associate is responsible for aspects of production, compilation, and submission of regulatory documents required for filing INDs, including original submissions, subsequent amendments and periodic reports to regulatory authorities. In addition, the position would entail regulatory document management responsibilities using Regenxbio’ s Veeva electronic document management system to manage and provide internal access to electronic copies of submissions and/or other regulatory communications.
- Assist in the review, authoring, and compilation of tabulated and written summaries needed for preparation of required components for IND submissions.
- Maintain regulatory timelines and eCTD tracking information coordinating completion of required components of IND by other contributing team members. Collaborate with contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions
- Work with outside regulatory information management companies to ensure a quality final submission and meet internal deadlines
- Act as Lead Publisher, for assign projects to publish and validates large and complex submissions to health authorities.
- Utilizes expertise to function as a trainer or subject matter expert for an area of eCTD and electronic publishing.
- Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs.
- Assists with archiving of documents within the Veeva document management system
- Provides additional support as needed for team communications on planning and logistics for health authority meetings and preparation of minutes
- Bachelor’s degree in a relevant scientific discipline and 5 years pharmaceutical experience and minimum of or 2 years eCTD regulatory operations experience
- IT capability and competence with identified systems and databases (Microsoft Office, document management and eCTD publishing systems, archiving software)
- RAPS certificate and experience with ISI ToolBox, Starting Point templates, and Veeva Vault a plus.
- Ability to work independently with minimal supervision on multiple projects simultaneously.
- Understanding of drug development and regulatory requirements (standards, quality, timeliness)
- Organizational and planning ability
- Strong attention to detail and quality
- Good interpersonal and communication skills
- Ability to manage and prioritize a variety of project tasks
- Experience working with interdepartmental project teams
REGENXBIO is an equal employment opportunity employer. We are committed to providing equal employment opportunities to all qualified individuals without regard to the following legally protected characteristics: race, color, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military/veteran status, or any other characteristic protected by local, state or federal law. We assure you that your opportunity for employment with REGENXBIO depends solely on your qualifications.