Regulatory Affairs Director directs the regulation process for products requiring governmental approval by ensuring that all necessary applications are filed and handling all government interactions. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Affairs Director requires a bachelor’s degree. Typically reports to top management. The Regulatory Affairs Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Regulatory Affairs Director typically requires 5+ years of managerial experience.
Director, Regulatory Affairs Job Description Template
Our company is looking for a Director, Regulatory Affairs to join our team.
Responsibilities:
- Direct and facilitate teams of international Regulatory Affairs professionals to support global product registrations;
- Work with Marketing and others to develop compliant product labeling. Review and approve product labeling for compliance with regulatory requirements;
- Lead the Regulatory Affairs function for the Patient Recovery business through active participation in functional leadership and decision teams;
- Review regulatory sections in development, quality, and supply agreements;
- Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required;
- Coordinate complex logistical details including team resourcing and project timeline planning; liaise with functional group representatives;
- Review, evaluate and approve Document Changes, especially those concerning significant (from a regulatory perspective) changes and revisions;
- Determine applicable registration requirements for medical devices in all countries in which products are to be registered;
- Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission;
- Review system generated reports and analytics used to identify and report suspicious orders;
- Lead and perform internal policy reviews for global regulatory guidance and regulations;
- Performs other duties as required;
- Maintain Regulatory records and files;
- Review changes in international laws and regulations and assess their impact and make recommendations to ensure compliance.
Requirements:
- Bachelors or advanced degree;
- An advanced scientific degree is strongly preferred;
- Track record of working with multiple internal departments like Clinical Operations, Program Management, R&D and Commercial;
- A Bachelor’s preferably in areas of life sciences, engineering, or quality assurance with 20+ years of experience is required;
- 3+ years of personnel management;
- or;
- At least five years of Drug Regulatory experience;
- A Master’s degree with 15+ years of experience is required.