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About our client
Our client is into brand and generic pharmaceutical products. It develops, manufactures, markets and distributes such products. The Corona-based specialty pharmaceutical company has one of the broadest product offerings in the U.S. generics industry and a track record of service excellence. It is well known as a reliable and low-cost provider of quality pharmaceutical products.
Position	Location
Regulatory Affairs Manager	Northern California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) File Abbreviated New Drug Application submissions and line extensions supplement submissions 2) Hold primary contact with regulatory authorities for assigned projects and products 3) Determine nature and scope of information to be generated successfully and file for the required regulatory documents 4) Keep management informed of significant regulatory issues that affect assigned products/projects 5) Direct, coordinate and prioritize daily activities of the Regulatory Affairs Department and assigned staff 6) Review and approve Abbreviated New Drug Application (ANDA) submissions to the Food and Drug Administration (FDA) and all documentation supporting an application 7) Interact with various departments as needed on regulatory issues and/or strategy 8) Communicate effectively and implement determined strategy with the appropriate departments and/or employees 9) Interact with the FDA to facilitate approval of the regulatory submissions 10) Maintain awareness of all regulatory activities on assigned projects 11) Work on minimizing regulatory issues and help prevent unnecessary regulatory delays 12) Interact with outside consultants and or contractors as needed 13) Troubleshoot data and resolve problems with technical issues such as test methods and instrumentation 14) Provide support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning and work assignment delegation 15) Conduct performance evaluations for direct reports 16) Meet project deadlines and established performance standards 17) Comply with all company policies and procedures, including safety rules and regulations and guide subordinates in this area
Requirements
1) Bachelor of Science degree from an accredited college or university 2) 6 years of experience in regulatory affairs pharmaceutical technical work combined with supervisory experience of 1 year; or an equivalent combination of education and experience 3) Experience in recruiting, interviewing and selection of applicants in accordance with established employment practices and methods 4) Experience in principles and practices of budget preparation and administration 5) Background in federal and state laws related to pharmaceutical regulatory affairs 6) In-depth knowledge of business, scientific and personal computer software applications 7) Knowledge of FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations 8) Ability to supervise training practice and methods 9) Ability to create, plan and implement group goals, objectives and practices for effective, efficient and cost effective management of allocated resources 10) Ability to respond to general and/or sensitive inquiries from management, employees and regulatory agencies 11) Ability to prepare, present and administer budgets and financial reports 12) Ability to communicate clearly and concisely (oral and written) 13) Ability to manage multiple projects, duties and assignments 14) Ability to interpret and apply federal, state and local policies, procedures, laws and regulations 15) Ability to direct, coordinate, delegate assignments and review the work of assigned department personnel 16) Ability to establish and maintain cooperative working relationships with others 17) Proficiency in business English usage such as, spelling, grammar and punctuation