Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a leading global speciality pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology, Women's Health and Nephrology (Medical). Watson has commercial operations in many of the world's most established and growing international markets.
Post: Regulatory Affairs Associate - III
Job Description:
Essential Job Functions:
Carries out responsibilities in accordance with the organization’s policies, procedures and federal, state and local laws.
Prepares timely original ANDAs, amendments, supplements, annual reports and other regulatory documents for review and approval by Manager.
Interfaces with other departments to provide Regulatory advice and obtain the necessary documents and draft reports and narrative components in accordance with regulatory agencies’ guidelines.
Prepares, assembles, complies and publishes regulatory submissions in electronic (eCTD) as required.
Reviews and approves change controls, assigning the appropriate regulatory determination for eventual submission as required.
Communicate with Regulatory Agencies as directed.
Reviews, analyzes and generates technical documents from other departments or companies, e.g. summary of manufacturing processes, clarifications and explanations of Company procedures.
Evaluates and researches any submission deficiencies, additional information or testing as requested by regulatory authorities.
Participates in problem solving activities for assigned projects.
Reviews and updates departmental SOP’s.
Performs special projects assigned by Regulatory Affairs management.
Complies with good housekeeping and safety practices.
Trains and coaches lower level Regulatory Affairs Associates.
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.
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Candidate Profile:
Knowledge of:
Current Food and Drug Administration (FDA) regulations and guidelines.
Current FDA/Regulatory Affairs submission requirements including eCTD format.
Logistics and work of the pharmaceutical industry.
Business, scientific and personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Current Company policies, practices and procedures including safety rules and regulations.
Skill in:
Responding to inquiries from management, employees and/or regulatory agencies.
Communicating clearly and concisely, both orally and in writing.
Operating a personal computer.
Managing multiple projects, duties and assignments.
Applying federal, state and local policies, procedures, laws and regulations.
Establishing and maintaining cooperative working relationships with others.
Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Minimum Qualifications:
Bachelor’s Degree in Chemistry or related field from an accredited college or university, and five (5) years work experience in the pharmaceutical industry or three (3) years of satisfactory performance as a Regulatory Affairs Associate II.
Additional Information:
Experience: 5 Years
Location: Corona, CA-USA
Education: BS-Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job ID: 7786BR
End Date: 29th Sept., 2011
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