|
Position Description
The essential duties for this position include, but are not limited to:
• Coordinates and participates in writing, preparation, assembly, and maintenance of market authorization and/or investigational drug submissions (electronic and paper) to regulatory authorities.
• Responsible for all communications with regulatory authorities.
• Performs due-diligence review of regulatory documents for potential acquisitions.
• Provide strategic and operational regulatory guidance and expertise to scientists on R&D project teams in a manner consistent with the Company’s objectives and interests.
• Coordinates and participates in preparation and revision of regulatory SOPs; presentations for meetings with FDA staff or advisory committees; and facilitates and prepares responses to queries from regulatory authorities.
• Manages and mentors direct report(s) assigning tasks commensurate with skill level, providing professional development, and performing appraisals and counseling.
• May serve as project manager or team member of various projects; travel of 10 to 35% as needed for coordination of activities in area of responsibility.
• Represents Regulatory Affairs on internal company committees
• Keeps abreast of current regulations, guidances, and trends.
• Appraise, motivate and direct staff to ensure continued development and professionalism; sets objectives, monitors progress and prepares annual performance appraisals.
Knowledge Necessary to Perform the Job:
• Thorough knowledge and experience with the Food and Drug Act, with Title 21 of the code of Federal Regulations, with regulatory guidance documents, and with other regulatory compliance and enforcement information.
• Extensive clinical and/or nonclinical pharmacology/toxicology hands-on experience preferred.
• Familiarity with legal, scientific, and pharmaceutical-related terms and basic understanding of GXP regulations and principles; RAC certification helpful but not required; experience with electronic regulatory submission software preferred; familiarity with legal, medical and scientific terminology.
Essential Skills
Qualifications:
An individual must have excellent interpersonal and diplomatic skills; be able to communicate with scientists and have a detailed understanding of scientific issues. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience:
MS/PhD/PharmD in scientific discipline or closely related field and 10 years of relevant experience in regulatory affairs or equivalent combination of education and experience. Medical/technical writing experience preferred.
|
