Regulatory Affairs Specialist

### Primary Responsibilities:

· Compile and maintain regulatory dossiers and data for company products (drug substance and drug product); prepare records and reports for submissions and keep track of progress.

· Assist in the management of project timelines and provide operational regulatory support to project teams and senior management; perform project evaluation and mitigation for ongoing and future projects.

· Track project timelines using Gantt charts, spreadsheets, and tools for project management.

· Assist with preparation of deficiency responses for global regulatory filings (FDA, EU, PMDA, CFDA, etc.).

· Maintain accurate records of all regulatory correspondence with partners, vendors, contract labs, CMOs, etc.

· Assist in preparing the site for customer and agency inspections, specifically for regulatory affairs; assist in preparing responses for customer and FDA deficiencies.

· Facilitate necessary document retrieval from different departments and other manufacturing sites.

· Evaluate process/specification changes and their impact on existing regulatory submissions.

· Notify customers regarding any regulatory dossier changes that might impact their product quality.

· Stay updated with new guidance documents and evaluate their impact on pre-existing and forthcoming projects.

· Schedule meetings and teleconferences as needed to resolve regulatory issues.

· Identify the need for resources and communicate to management.

· Other responsibilities as assigned.

### Qualifications:

· Minimum BS/BA degree in chemistry or life science; RAC and/or graduate-level courses in regulatory affairs desired.

· Minimum 2 years of relevant experience, ideally in the biotechnology or pharmaceutical industry.

· Familiarity with regulatory requirements for the development of drug and biological products, including FDA and EMEA regulations and guidance, as well as ICH and USP guidelines.

· Demonstrated ability to coordinate and work effectively with cross-functional teams.

· Oversee all project activities on a day-to-day basis to ensure on-time completion of planned tasks.

· Communicate and monitor the project functional tasks for operation teams, research and development, sales, and marketing.

· Excellent verbal, written, and interpersonal communication skills.

· Strong attention to detail.

· Good organizational and time management skills; ability to work on multiple projects and adhere to timelines.

· Willingness to advance knowledge of regulatory practice through classes, certifications, webinars, etc.

· Ability to shift priorities according to changes in department/facility needs and be open to different ideas and approaches.

· Highly motivated, self-empowered, responsible, takes initiative, and applies innovative solutions to solve problems.

· Technical expertise with Windows, MS Office (Outlook, Word, Excel, Project, PowerPoint), Adobe Acrobat software systems, and experience working in an electronic document management system.

### ADA Requirements (Condition of Employment):

· Must be able to walk, sit, or stand in a stationary position with or without assistance.

· Must be able to push, pull, squat, stand, and walk throughout the day.

· Must be able to lift up to 20 lbs.

· Must be able to wear safety shoes and glasses throughout the day while in designated areas (provided by the company).

· Must be cleared by a physician to wear a respirator throughout the day while in designated areas.

· Must be able to work in a chemical environment.

Call (803) 442-7590 for more information on how to apply.