Activities Core responsibilities include:

Preparation, updating, and coordinated submission of Drug Master Files (DMFs) for Copperhead's active pharmaceutical ingredients (APIs) in accordance with regulatory requirements. Communicates with the U.S. FDA and other regulatory agencies/health authorities, as required, including notification of changes to DMFs and responding to agency related questions and/or deficiencies. Reviews all internal change control documents to assess the impact on Copperhead's products, DMFs and customer regulatory approvals; provides the required notifications to customers and regulatory authorities as deemed necessary. Provides appropriate information and assistance to customers relating to same. Keeps appraised of regulatory laws, regulations, and guidance's governing pharmaceutical products as issued by the FDA and other regulatory agencies, as well as current industry practices. Participates in monthly meetings of the industry group, Bulk Pharmaceutical Task Force (BPTF). Advises Management and senior staff of regulatory changes that may affect the company's products. Participates as a member of the Tamaqua Operations' Validation Committee. Prepares and updates Quality Assurance Procedures principally related to pharmaceutical regulatory affairs, such as the DMF customer notification and recall procedures, and fulfills the tasks conveyed therein as well as in other quality system documentation. Provides guidance for development efforts for existing and new pharmaceutical products. Prepares and responds to requests for regulatory statements for Copperhead's products. Reviews and prepares Quality Agreements in collaboration with individual customers and Quality Assurance. Other duties as assigned. Accountability Strong understanding and experience with pharmaceutical regulations and cGMP requirements. Strong verbal and written communications skills are essential. Meets commitments, deadlines, and follows up effectively. Ability to work with minimal supervision. Ability to engage positively with regulatory agency personnel, customers at all levels, and plant and corporate personnel. Ability to work in a team environment to ensure Copperhead's manufacturing operations and pharmaceutical products meet regulatory requirements.

Qualifications / Experience

Required Bachelor's degree in a science-related discipline (Chemistry, Biology or Pharmacy) or other related field. 5+ years of progressive regulatory experience within the pharmaceutical industry Experience with cGMP requirements. Good interpersonal and people management skills. Working Conditions The job holder will work primarily in an office environment and must be willing to multi-task between various responsibilities to accomplish the day's requests. Some travel may be required to visit customers or for off-site meetings or training. Ability to get along and communicate with others as required. Employee Requirements Copperhead employment is contingent upon a current valid driver's license and acceptable results of a pre-employment physical exam including drug and alcohol screening, PA State Police criminal record background check and Explosives Employee Possessor background clearance from the Bureau of Alcohol Tobacco and Firearms.

Job Type:

Full-time Benefits:

401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): Do you have a current valid driver's license ? Are you willing to undergo a pre-employment physical exam, including drug and alcohol screening ? How many years of regulatory affairs specialist experience do you have?

Work Location:

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