Provide regulatory leadership by developing, driving, and implementing regulatory strategies for assigned

Participates in the strategic decision making of Product Development Leadership Team (PDLT).  Participates in due diligence evaluation of licensing opportunities and contract review on relevant projects.  Represents Regulatory Affairs on Commercial Compliance Committee and participates in the strategic decision making.  Provide guidance to upper management regarding regulatory strategy.  Responsible for Pharmacovigilance Activities for all Noven products, including oversight of operations.  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.
• Direct and/or oversee the coordination and preparation regulatory submissions (INDs, NDAs, ANDAs and amendments/supplements
• 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.
• Provide guidance on risk assessments for promotional materials
• Oversee pharmacovigilance activities
• May serve as project team leader
• Maintain current knowledge of regulatory environment; interpret impact on company practice.

Competencies:

Education / Experience:

Bachelor’s degree in a scientific discipline, and 12 years of professional experience in regulatory affairs. A master’s degree and 9 or more years of previous experience in a related field can substitute for some or all of the required education in related field. 

Demonstrated expertise/knowledge of core processes: discovery, manufacturing development and marketing. Knowledge of FDA and other regulatory guidelines. Experience in women’s health or CNS therapeutic areas 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, operating computer. 

Physical Demands:         

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