Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.
Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.
May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department
Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
Seeks assistance from appropriate internal and external resources.
Knowledge and Skills
Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.
Strong verbal and written communication skills and interpersonal skills.
Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
Proficiency in Microsoft Word and Excel.
Experience with Microsoft Power Point, Project and Visio a plus.
Act as a resource on limited topics within the department.
Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.
Education and Experience
4+ years of relevant training or industry experience with BS/BA.
3+ years relevant training or industry experience with advanced degree.
Degree in a scientific field is preferred.