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Sr. Manager Regulatory Affairs, DEA Allegan United States,
Posted on : 30 June 2017
This position is responsible for the DEA Corporate Compliance Program and State Licensing compliance for Rx and OTC products under development and commercial product maintenance. Position has responsibility as cross-functional lead to ensure partner departments understand their respective roles & responsibilities related to DEA compliance. Responsibility includes supervising and leading non-exempt and/or exempt direct reports.
- Establish and lead DEA inspection team, ensure related activities such as the inspection preparation room are managed effectively and efficiently, appropriately delegate inspection related activities to direct reports or partner department staff.
- Ensure staff involved with DEA inspections are trained and records retained appropriately.
- Manage daily activities related to the DEA Corporate Compliance Program and State Licensing compliance such as, but not limited to, theft/loss investigations and reporting, suspicious order monitoring, import/export records, and quotas.
- Monitor regulatory environment related to DEA and State Licensing directly, with assistance from direct reports, and consultants.
- Contact DEA or outside consultants to resolve regulatory issues and negotiate directly as required.
- Ensure regulatory files and data systems are maintained in compliance with internal SOPs.
- Represent regulatory affairs in project meetings and provide regulatory commitments as required.
- Communicate and collaborate with senior management in all areas of the company.
- Support a continuous improvement environment and develop staff to execute continuous improvement projects.
- Provide oversight for RA processes and systems.
- Hire, train, coach/mentor and evaluate performance of direct reports.
- Assign, balance and prioritize workloads of direct reports.
- Ensure quality of all agency submissions and communications.
- Projects as assigned by management.
- Supervises non-exempt and/or exempt direct reports.
- Must possess advanced analytical skills and the ability to identify and apply DEA and State Licensing policies and general regulations to specific products or projects and create new policies as required.
- Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for stakeholders inside and outside of Regulatory Affairs.
- Advanced verbal and written presentation and communication skills are necessary.
- The ability to effectively lead project teams is required.
- Advanced knowledge of scientific, regulatory, DEA, State Licensing and legal terminology is necessary.
- These skills are normally acquired through possession of a Bachelor Degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined with 8-10 years of experience in the health care or pharmaceutical industry and 7+ years of hands on experience in DEA and State Licensing activities.
- 7 or more years of experience in direct supervision.
- Advanced degree preferred.
Allegan Michigan United States
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