Assoc Dir, Regulatory Affairs Generic

Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.This position, oversees, directs, coordinates and prioritizes the daily activities for the assigned areas of the Regulatory Liaison, Generic Products department. The incumbent provides support, direction and coaching to subordinate employees for both domestic and
international, post-approval generic applications. Also assures that project deadlines and performance standards are met. Oversees, directs, coordinates and prioritizes the daily activities of assigned staff in the Regulatory Liaison, Generic Products Department.
Reviews and approves the compilation of post-approval supplemental new drug applications and other types of submissions to applicable domestic and international Regulatory Agencies.
Works with management to assure that Regulatory Agencies' reviewer's comments are addressed and the company responses are submitted. Follows up on pending approvals for post-approval supplements and obtains approval on a timely basis. Maintains all post
approval activities.
Carries out managerial responsibilities in accordance with the organization's policies, procedures and state, federal and local laws.
Oversees, participates and approves the interviewing, hiring, and training of assigned departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units.
Trains or participates in training subordinates in the preparation of documentation for regulatory review in technical areas and in current Good Manufacturing Practices (cGMP).
Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
Ensures project deadlines and performance standards are established and met.
Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Performs related duties, as assigned.Qualifications
Four (4) to eight (8) years of Regulatory Affairs pharmaceutical work experience, or an equivalent combination of education and experience.
Required knowledge and skills:
Supervision and training practices and methods.
Pertinent Federal and State laws related to pharmaceutical regulatory affairs.
Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
Preparing, presenting and administering budgets.
Establishing and maintaining cooperative working relationships with others.
Responding to complex and sensitive inquiries from management, employees and regulatory agencies.
FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations.
Adherence to applicable regulations from regulatory agencies.
Business, scientific and personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
Current Company policies, practices and procedures, including safety rules and regulations.
Communicating clearly and concisely, both orally and in writing.
Interpreting and applying domestic Federal, state and local policies, procedures, laws and regulations.
Ensuring compliance with all Company policies and procedures, including safety rules and regulations.Watson offers competitive medical and dental benefits, including vision, 401(k) and educational reimbursement.Watson Pharmaceuticals, Inc. is an Equal Opportunity Employer M/F/D/V. We value the benefits of diversity.Apply Online Now!
REQUIREMENTS
Please see Job Description