Senior Regulatory Affairs Specialist

DESCRIPTION This position will provide support on regulatory projects for clients and guidance on regulatory affairs issues to the Aptuit Consulting team and Aptuit operational staff. Assumes responsibility for assigned regulatory projects, including assuring quality, completeness, and timeliness of reports, regulatory documents, and dossiers.

We are currently seeking an Associate to join the Consulting team. Candidates must have prepared, managed preparation of, and maintained regulatory documents and dossiers, eg, INDs, CTAs, NDAs, CTDs, etc. as well as demonstrated knowledge and application of current pharmaceutical regulations and guidance documents to various regulatory projects/situations.

Responsibilities include manage compilation and submission of regulatory documents and dossiers for submission to clients and regulatory authorities, assume responsibility for assigned regulatory projects, including assuring the quality, completeness, accuracy and timeliness of the project, work closely with Aptuit Consulting team, communicate routinely with management on team project progress and notify of any major issues immediately. Assure final product meets customer expectations, act as resource on regulatory issues, willing to mentor other regulatory associates, assist in identification of regulatory information, maintenance of regulatory files, and provide support to Aptuit Consulting and Aptuit Operations. ? ?REQUIREMENTS Candidates must have BS in scientific discipline, experience preparing regulatory documents and dossiers and demonstrated knowledge and application of current pharmaceutical regulations and guidance documents to various regulatory projects/situations. Skilled in problem solving, analysis, project management, and verbal and written communications, exceptional organizational skills, ability to prioritize multiple projects, and attention to detail and team-oriented attitude. Good proficiency in computer skills, particularly Microsoft Word and Adobe Acrobat.
Please submit salary requirements along with your resume.

Aptuit offers a very comprehensive and competitive benefits program.
We are an Equal Opportunity Employer M/F/D/V.