Manager, Regulatory Affairs Non-Sterile
Company Name:
Teva Pharmaceuticals USA, Inc.
Manager, Regulatory Affairs Non-Sterile. Teva Pharmaceuticals USA, Inc., Horsham, Pennsylvania. Responsible for management of staff of regulatory associates and supervision of regulatory submissions in a Chemistry, Manufacturing, and Controls (CMC) environment. Key duties include: critical review of submissions and documents prepared by regulatory associates, including change control documents, original Abbreviated New Drug Applications (ANDA) and ANDA amendments/supplements, and responses to FDA queries; ensuring that submissions are in accordance with Food and Drug Administration (FDA) and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) regulations and guidelines; overseeing the entire drug product submission lifecycle, including component tracking, workflow execution, and issue resolution; coordinating and facilitating the flow of information from R&D, manufacturing sites, labeling and supply chain for documents review; ensuring that regulatory activities satisfy established timelines and performance standards; developing appropriate strategies to ensure correct categorization of regulatory filings; communication with FDA as necessary; monitoring regulatory developments; and representing the Regulatory Affairs department during interdepartmental projects. Must have a Bachelors degree (or the foreign equivalent) in chemistry, pharmacy, pharmaceutical sciences, or related field, plus five years of progressively responsible generic pharmaceutical Regulatory Affairs experience. The qualifying experience must have been in an FDA and ICH regulated Chemistry, Manufacturing and Controls (CMC) environment. Candidates must have developed the regulatory approval strategy and led the implementation of that strategy with respect to a minimum of 10 successful complete original ANDA submissions. Development of regulatory approval strategy must have included guiding R&D on new drug products formulation development based on (1) analysis of inactive ingredients database (IID), (2) analysis of FDA, SBA and EPAR databases, and (3) drafting controlled correspondences as necessary. Of the minimum 10 successful complete original ANDA submissions: (1) there must have been at least one of each of the following dosage forms/routes of administration - solid orals, pellets, mini tablets, transdermal, suspensions and solutions; and (2) at least five must have incorporated Quality by Design (QbD) elements. Candidates must have conducted the Regulatory Assessment of at least five previously submitted ANDAs and developed an action plan for anticipated deficiencies. At least three years of the qualifying experience must have included mentoring and training junior regulatory affairs staff. Candidates must have experience in representing the regulatory affairs function as part of a multidisciplinary due diligence team, including conducting technical assessments and regulatory affairs analyses, in connection with at least two licensing, manufacturing and/or product development transactions with third parties. Please refer to Job Code MRANS2015 and send resumes to Teva Pharmaceuticals USA, Inc., 1090 Horsham Road, North Wales, PA 19454. Attn: HRGM6635.Estimated Salary: $20 to $28 per hour based on qualifications.
Teva Pharmaceuticals USA, Inc.
Manager, Regulatory Affairs Non-Sterile. Teva Pharmaceuticals USA, Inc., Horsham, Pennsylvania. Responsible for management of staff of regulatory associates and supervision of regulatory submissions in a Chemistry, Manufacturing, and Controls (CMC) environment. Key duties include: critical review of submissions and documents prepared by regulatory associates, including change control documents, original Abbreviated New Drug Applications (ANDA) and ANDA amendments/supplements, and responses to FDA queries; ensuring that submissions are in accordance with Food and Drug Administration (FDA) and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) regulations and guidelines; overseeing the entire drug product submission lifecycle, including component tracking, workflow execution, and issue resolution; coordinating and facilitating the flow of information from R&D, manufacturing sites, labeling and supply chain for documents review; ensuring that regulatory activities satisfy established timelines and performance standards; developing appropriate strategies to ensure correct categorization of regulatory filings; communication with FDA as necessary; monitoring regulatory developments; and representing the Regulatory Affairs department during interdepartmental projects. Must have a Bachelors degree (or the foreign equivalent) in chemistry, pharmacy, pharmaceutical sciences, or related field, plus five years of progressively responsible generic pharmaceutical Regulatory Affairs experience. The qualifying experience must have been in an FDA and ICH regulated Chemistry, Manufacturing and Controls (CMC) environment. Candidates must have developed the regulatory approval strategy and led the implementation of that strategy with respect to a minimum of 10 successful complete original ANDA submissions. Development of regulatory approval strategy must have included guiding R&D on new drug products formulation development based on (1) analysis of inactive ingredients database (IID), (2) analysis of FDA, SBA and EPAR databases, and (3) drafting controlled correspondences as necessary. Of the minimum 10 successful complete original ANDA submissions: (1) there must have been at least one of each of the following dosage forms/routes of administration - solid orals, pellets, mini tablets, transdermal, suspensions and solutions; and (2) at least five must have incorporated Quality by Design (QbD) elements. Candidates must have conducted the Regulatory Assessment of at least five previously submitted ANDAs and developed an action plan for anticipated deficiencies. At least three years of the qualifying experience must have included mentoring and training junior regulatory affairs staff. Candidates must have experience in representing the regulatory affairs function as part of a multidisciplinary due diligence team, including conducting technical assessments and regulatory affairs analyses, in connection with at least two licensing, manufacturing and/or product development transactions with third parties. Please refer to Job Code MRANS2015 and send resumes to Teva Pharmaceuticals USA, Inc., 1090 Horsham Road, North Wales, PA 19454. Attn: HRGM6635.Estimated Salary: $20 to $28 per hour based on qualifications.
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