European Union Regulatory Affairs, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Working under minimal supervision, the Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategy for the global regulatory functions. This person has oversight responsibility for Regulatory consultants. This position coordinates planning, manages multiple projects and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. The position requires acting as the liaison with the FDA and other global regulatory agencies with responsibility for global regulatory submissions. This person has strong knowledge and skills in Regulatory pathways, options and documentation requirements to support portions of a project or a Regulatory filing.
Performs varied Regulatory activities such as gathering content for a Regulatory filing, reviewing relevant guidance, and reviewing data to ensure accuracy for Regulatory filing purposes or in support of regulatory databases used to support the organization
Develops and manages regulatory submissions and related supplements and amendments
Works independently to accomplish established Regulatory objectives following specific aspects of selected Regulatory strategy
With training, can support maintenance of existing simple licenses/certificates and assist with the compilation of submission
Develops or participates in the development of Regulatory solutions to problems involving several concrete variables in, or from, standardized situations of moderate to low complexity that may affect a narrow functional area
May work with manufacturing, engineering, and other functional groups to gather Regulatory content for Regulatory filings or to address a potential Regulatory compliance issue
Maintains regulatory required records per record retention requirements, assisting with maintaining submission databases and archiving
Updates and maintains Regulatory filing history for a given product line
The scope of Regulatory support offered to internal customers may be related to the short-term and intermediate objectives of the department
Offer recommendations for improvements in office practices and process flow as identified.
May provide support to other departments, as needed.
Minimum 10 years experience working in Regulatory Affairs, Previous FDA submissions experience
Requires learned knowledge plus limited understanding of the basic principles, theories, practices, and concepts of Regulatory Affairs
Basic knowledge and skills in regulatory pathways, options, and documentation with portions of projects
Possess interpersonal and organizational savvy
Knowledge and use of relevant PC software applications and skills to use them effectively
Demonstrated ability to communicate effectively both verbally and in writing with direct FDA interaction experience required