| Regulatory Affairs Mgr - Pharma |
Job Id: W162667 |
Posted On: 1/9/2010 |
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Location: Lancaster, PA;
Job Type: Full Time
Salary: $100.00 to $120.00/year
Degree: Bachelor of Science
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Description
CHARACTERISTICS OF THE CLASS:
The incumbent is responsible for providing the management of the Worldwide Department for the COMPANY Professional/Pharmaceutical Division. This job function includes insuring the establishment of regulatory standards and regulatory direction/guidance for the COMPANY Professional/Pharmaceutical Division. The primary responsibility is to develop and maintain appropriate global regulatory systems, standards and processes, and to establish successful relationships with global regulatory agencies. The position includes regulatory responsibilities for pharmaceuticals.
ESSENTIAL DUTIES:
Day-to-day management of Worldwide Regulatory Affairs Department.
Assist in identifying, assessing, implementing and managing all necessary regulatory needs of the division with contract manufacturers through the regulatory activities of an ongoing pharmaceutical division.
Prepare, compile and submission of domestic and international regulatory submissions and reports for new products, maintenance of established product lines and modifications to established products. Provide Regulatory Affairs consulting in support of global submissions.
Act as Corporate liaison with worldwide regulatory agencies.
Ensure that any process change that requires regulatory approval is identified and submitted to the proper regulatory authorities prior to implementation.
Liaise with global marketing authorization holders to manage and ensure compliance of regulations and submissions and provide regulatory strategy as required.
Conduct ongoing regulatory intelligence program which identifies the current regulatory global environment with providing impact assessment requirements that can affect the COMPANY Pharmaceutical business.
Management of Worldwide Regulatory Contract Research Organizations (CROS).
Development and maintenance of divisional regulatory affairs/compliance SOPs.
Coordination and management of divisional product labeling systems.
Supervision of Regulatory Affairs staff.
Act as regulatory resource for the division.
May be responsible for reviewing, documenting, logging, maintaining and/or initiating the investigation for potentially serious complaints.
Manages personnel within group with responsibilities to include staffing, performance management, development and coaching, training, and application of policies, programs, and procedures. Assures that a positive employee relations environment is maintained through effective communication.
MINIMUM QUALIFICATIONS:
A Bachelor of Science Degree in Life Science or a related field. An advanced degree is preferred.
A minimum of 6 years experience in (a pharmaceutical regulatory environment or CRO or Biopharmaceutical industry (CFR parts 210/211-Delete this reference to the regulations), including start-up of contract manufacturers, regulatory compliance and submissions.
Working knowledge of regulatory affairs and the FDA, current cGMPs/GCPs and GLPs, pharmaceutical product testing requirements, FDA and ICH guidelines.
Strong hands-on experience with worldwide regulatory planning and submission preparation and negotiation.
A Regulatory Affairs Certification (RAC) is preferred, but not required.
Strong organizational skills, basic computer skills (i.e. Word, Excel, Internet, Lotus Notes, QUMAS, Trackwise) and communication skills.
Travel 10% of the time is required, both domestic and international.
Ability to work in worldwide, multicultural organization.
PHYSICAL REQUIREMENTS:
Able to use standard computer equipment.
Able to stand and sit for minimum 15 minute periods.
WORKING CONDITIONS:
Occasional exposure to pharmaceutical manufacturing environment.
Travel is required.
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