Provide regulatory leadership by developing, driving, and implementing regulatory strategies for assigned products. Serve as key interface with the U.S. Food and Drug Administration (FDA) for assigned products. Demonstrate leadership within and across functions to achieve business objectives.

Assignment to the various levels is approved by Corporate Compensation and is based on the required knowledge in the field of work, years of experience, on-going responsibility for highly complex assignments, significance of the scope of responsibility, and the job function's considerable impact within the department and the company, as well as the reporting relationship and required supervisory responsibility.

• Develop and drive regulatory strategies for complex high business priority assigned products.
• Provide recommendations on health authority interactions and act as key interface with FDA and other health authorities as appropriate.
• Ensure regulatory strategic options, assessments, and risks are communicated to regulatory management and project team.
• Ensure regulatory management is informed of key regulatory activities and critical issues.
• Coordinate production of documents for marketing approval applications; ensure that submissions are of the highest quality and prepared according to established timelines.
• Manage review process for applications with FDA to facilitate approvals in line with business objectives.
• Develop regulatory packages and documents that meet regulatory and departmental guidelines.
• Coordinate activities of other regulatory personnel and cross functional teams to ensure tasks are completed within defined due dates.
• Recommend changes to labeling, manufacturing, marketing strategies, and clinical protocols based on available data for regulatory compliance.
• Maintain current knowledge of regulatory environment; interpret impact on company practice.

Competencies:

Education / Experience:

Bachelors, Master's, or doctoral degree in a scientific discipline, and 8 years of professional experience in regulatory affairs. Demonstrated expertise/knowledge of core processes: discovery, manufacturing development and marketing. Knowledge of FDA and other regulatory guidelines. Experience in transdermal delivery desirable. Recent experience of NDA, sNDA or ANDA filings desirable. Demonstrated command of core competencies listed below.

Judgment / Decision Making:

Establishes and implements strategies with direct impact on departmental / functional results.  Develops and implements initiatives, processes and goals for departmental / functional area within overall area of responsibility. Recommends policies, methods, processes, techniques for the business function based on change initiatives; creates / conceptualizes new methods, techniques, and /or processes across job areas or functions.

Work Environment:

Majority of time spent in office environment.

Physical Demands:         

Visual acuity and manual dexterity required to operate computer and proofread documents.    

The Expected Salary Range for this position is $172,740 - $259,000 annually.

Noven Pharmaceuticals offers a comprehensive benefits package that includes medical, dental, vision and other voluntary and company-paid benefits. A 401(k) Retirement Plan with company match is also offered. Additional benefits include educational reimbursement and other employee support programs.