Summary:
Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of *** s products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
" Initiate and develop complex regulatory project plans
" Identify & prioritize key areas of regulatory risk
" Monitor applicable regulatory requirements
" Create and maintain regulatory files in a format consistent with requirements
" Provide regulatory advice to project teams.
" Respond to complex questions from regulatory authorities within strict timelines
" Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
" Maintain and update existing regulatory authorizations
" Manage regulatory activities relating to specific portfolio of products/projects
" Prepare, review, and approve labeling and SOP s
" Lead or represent Regulatory Affairs in project teams
" Provide guidance and coaching for areas of responsibility to lower level team members
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op
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" Knowledge of regulations
" Scientific knowledge
" Project management skills
" Manage multiple projects and deadlines
" Ability to multitask and prioritize
" Interpersonal and communication skills
" Strong negotiation skills
" Technical system skills (e.g. word processing, spreadsheets, databases, online research)
" Ability to work effectively in multinational/multicultural environment
" Ability to identify compliance risks and escalate when necessary
Education and/or Experience:
Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Bachelor s degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization. FDA regulations and knowledge