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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
This position is responsible for supporting all regulatory projects in conjunction with other regulatory and clinical professionals.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Assist in the preparation of regulatory submissions, e.g., FDA IND supplements and international clinical trial applications (CTA).
Coordinate submission components, perform final preparation, assembly, formatting, editing, proofreading, and quality control of regulatory documents.
Prepare new investigator information, routine protocol amendments, and other information amendment submissions to US FDA and work with International contract groups to ensure submission to foreign agencies.
Coordinate input into clinicaltrials.gov in conjunction with clinical department to ensure information is accurate and properly reviewed prior to release
Search and retrieve submissions from regulatory archives
Coordinate department projects, meetings, and conferences both internal and external with other departments, regulatory agencies, partners, and consultants.
Back up for editing regulatory documents in preparation for final submissions.
Oversee completion of general department activities.
Required Education and Experience
Typically requires a Bachelor's degree with zero to 2 years of related experience. Without degree, additional related experience is required.
Additional Eligibility Qualifications
Up to two years’ experience assisting in the preparation of regulatory documents including editing, proofreading, layout and document preparation.
At least 2 years’ experience in the pharmaceutical industry in a documentation management role highly desirable
Advanced use of Microsoft Word and other Microsoft Office products, Adobe Acrobat, and database programs.
Experience with eCTD publishing software desirable.
Familiarity with regulatory practices, principles, and ICH eCTD submission structure.
Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.