Regulatory Affairs ManagerSummaryElements of Position: Under general direction and using government guidances and regulations, responsible for successfully filing ANDA submissions, supplement submissions, Annual Reports and Adverse Event Reporting.

Determines nature and scope of information to be generated to successfully file required regulatory documents.

Keeps company informed of significant regulatory issues that affect assigned products/projects.

Essential Job Functions: (not intended to be a comprehensive list)· Detail review of documents and regulatory submissions to ensure clarity of data presentation, accuracy of data interpretation, logic, consistency and compliance with Regulatory requirements.

· Anticipates regulatory issues early in drug development process and works to eliminate/minimize regulatory barriers to prevent unnecessary regulatory delays.

· Determines necessity for communication with FDA for technical issues.

Negotiates agreements on issues needing further clarification.

· Develops and implements regulatory strategies/advice for new product development and life cycle of the product.

Communicates regulatory information to product team members.

Maintains awareness of all regulatory activities on assigned projects.

· Develops submission strategies for manual and electronic submissions of new ANDAs, supplements and annual reports.

· Provides draft labeling (labels, package inserts, and cartons) for submission.

· Reviews change control in order to assign appropriate regulatory determination and ensure proper supporting documentation is available to accurately define change.

· Provides support, direction and coaching to subordinate employees in the areas of training, disciplinary action, problem resolution, planning, and work assignment delegation.

Conducts performance evaluations for direct reports.

· Ensure compliance with all Company policies and procedures, including safety rules and regulations · Carries out managerial responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.

Required Knowledge: · Strong familiarity with USP, FDA, ICH and cGMP standards, guidelines, regulatory compliance regulations and the overall regulatory environment as related to the pharmaceutical industry.

Aware of pertinent Federal and State laws related to pharmaceutical regulatory affairs.

Ability to apply appropriate regulations to resolve the regulatory issue.

· Strong familiarity of the drug development process.

Ability to proactively assess appropriateness of data.

· Business, scientific and personal computer software applications, e.

g MS Word, Excel, Access, etc.· Business English usage such as, spelling, grammar and punctuation.

Minimum Qualifications: Bachelors of Science Degree from an accredited college or university, and three (3) to five (5) years Regulatory Affairs pharmaceutical technical work experience or an equivalent combination of education and experience.

Required Skills: · Create, plan and implement team goals, objectives and practices for effective, efficient and cost effective management of allocated resources.

· Respond to general and/or sensitive inquiries from management, employees and regulatory agencies.

Establish and maintain co-operative working relationships with key clients and contacts within the organization.

· Communicate clearly and concisely, both orally and in writing, when interpreting and applying Federal, state and local policies, procedures, laws and regulations.

· Manage multiple projects, duties and assignments.

· Analyze problems, identify alternate solutions, and implement recommendations for resolution.

Formulate and provide supporting data for the Companys position on specific issues in light of current regulatory strategy.

Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and frequent business travel.

Work is performed in an office environment.

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