Manager, Regulatory Review
3 weeks ago
The Manager, Regulatory Review manages a team of Associates and Senior Associates to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical clients for regulatory review. You will contribute in establishing procedures for our teams and advising on specific projects to aid smooth and fast review by clients. You will report to the Director, Regulatory Promotional Operations.
This is a hybrid role, requiring three days in-office each week. If you are contacted for an interview, your recruiter will discuss specifics with you, inclusive of any necessary reasonable accommodations.
Your Impact:
Manage multiple direct reports at the Associate, Senior Associate, and Manager level including responsibility for interviewing, hiring, onboarding, and career development
Provide estimates for SOW development
Work with the Director, Regulatory Review in the development of departmental SOPs
Oversee work of reporting employees on daily basis, providing advice on projects, and addressing problems as they arise
Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage
Determine the time and effort required to complete each submission
Establish a timeline and assign responsibility to the appropriate team members for delivering the components of the submission
Oversee the creation of the components and ensure they conform to client and Digitas Health guidelines
Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
Follow up with client liaison promptly to ensure the submission is received on time and meet 100% of client expectations and specifications
Maintain to the department procedure(s) specific to the clients supported
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Philadelphia, Pennsylvania, United States Digitas Health Full timeJob Description The Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and...
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Manager, Regulatory Affairs-hybrid
3 weeks ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...
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Manager, Regulatory Affairs-hybrid
2 weeks ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...
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Regulatory Operations Coordinator
4 days ago
Philadelphia, United States Piper Companies Full timePiper Companiesis looking for aRegulatory Operations Coordinatorto be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA .Responsibilities for the Regulatory Operations Coordinatorinclude: Work with internal teams and stakeholders to build IND & CTA dossier content plans and...
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Associate/Manager – CMC Regulatory
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Regulatory Operations Coordinator
6 days ago
Philadelphia, United States Piper Companies Full timePiper Companies is looking for a Regulatory Operations Coordinatorto be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinatorinclude: Work with internal teams and stakeholders to build IND & CTA dossier content...
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Regulatory Operations Coordinator
7 days ago
Philadelphia, United States Piper Companies Full timePiper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...
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Sr. Regulatory Specialist
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Regulatory Publishing Specialist
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Associate Director, Regulatory Operations-hybrid
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Associate Director, Regulatory Operations-hybrid
2 weeks ago
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Senior Attorney
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Regulatory Operations Coordinator
6 days ago
Philadelphia, PA, United States Piper Companies Full timePiper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA . Responsibilities for the Regulatory Operations Coordinator include: Work with internal teams and stakeholders to build IND & CTA...
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Vice President, Regulatory Consulting
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Philadelphia, United States Adaptimmune Therapeutics plc Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
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Regulatory Operations Coordinator
7 days ago
Philadelphia, PA, US Piper Companies Full timePiper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...
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Regulatory Operations Coordinator
6 days ago
Philadelphia, PA, US Piper Companies Full timePiper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...
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Philadelphia, United States Adaptimmune Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
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Sr. Regulatory Operations Specialist
6 days ago
Philadelphia, United States Piper Companies Full timePiper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist · Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders,...