Regulatory Affairs Director
2 days ago
At Extremity Care, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our leadership team, you will be responsible for ensuring that our organization remains compliant with all relevant regulatory requirements.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
- Support the organization's strategic objectives and ensure that regulatory affairs are aligned with business goals.
- Direct and oversee internal audit programs to ensure compliance with regulatory requirements.
- Facilitate external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
- Serve as the primary regulatory contact and maintain effective relationships with regulatory agencies.
- Direct and oversee supplier management programs to ensure compliance with regulatory requirements.
- Oversee regulatory review of procedures, marketing, and sales promotional label/labeling materials.
- Oversee regulatory review and approval for closure of deviations, nonconformances, complaints, CAPAs, SCARs.
- Author/revise procedures according to FDA, AATB, and other regulations.
- Oversee management of submissions of FDA/AATB reportable events.
- Direct and oversee management of state license application submissions and renewals.
- Oversee management of unique device identifiers (UDI) submissions and renewals.
- Oversee management of regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
- Support the development of qualification/validation protocols and verify compliance with regulatory requirements.
- Review and approve validation/verification/qualification plans, protocols, execution data, and summary assessments to verify compliance with regulatory requirements.
- Direct and oversee monitoring programs for regulatory updates and internal compliance evaluation.
- Monitor FDA activities, to include enforcement actions, warning letters, and 483s to analyze and report on company impact.
- Collaborate with Product Development & Management to establish & support project timelines.
- Provide regulatory oversight, support, and approval for new projects and products.
- Integrate shared leadership and foster collaboration across multi-disciplinary teams for project groups.
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations' policies and procedures.
- File and maintain records in accordance with standard operating procedures.
- Manage direct reports.
- Establish and monitor objective annual goals for direct reports.
- Conduct performance reviews and establish performance improvement plans as needed.
- Recruit, interview, and select personnel for hire.
- Attend/participate in offsite business meetings/conferences.
- Start job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
- Perform other related duties as assigned.
- Bachelor's degree in a biological science or related field required.
- Master's degree preferred.
- At least years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience.
-
Regulatory Affairs Director
4 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob Title: Regulatory Affairs DirectorMadrigal Pharmaceuticals Corporation is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for managing the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed.Key Responsibilities:Develop...
-
Regulatory Affairs Director
2 days ago
Conshohocken, Pennsylvania, United States Extremity Care Full timeJob Title: Director of Regulatory AffairsAt Extremity Care, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for ensuring compliance with FDA and state regulations, as well as maintaining effective relationships with regulatory agencies.Key...
-
Regulatory Affairs Director
2 weeks ago
Conshohocken, Pennsylvania, United States Extremity Care Full timeJob DescriptionAt Extremity Care, we are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for ensuring compliance with FDA and state regulations, as well as maintaining effective relationships with regulatory agencies.Key Responsibilities:Create and implement...
-
Regulatory Affairs Director
11 hours ago
Conshohocken, Pennsylvania, United States Extremity Care Full timeJob SummaryExtremity Care seeks a highly skilled Regulatory Affairs Director to oversee all regulatory matters, ensuring compliance with FDA and state requirements, AATB Standards, and other applicable regulations.Key ResponsibilitiesCreate and implement regulatory strategies and solutions to ensure compliance with FDA and state requirements, AATB Standards,...
-
Regulatory Strategy Director
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob SummaryMadrigal Pharmaceuticals Corporation is seeking a highly skilled Regulatory Strategy Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.Key Responsibilities:Develop and implement...
-
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewThe Senior Director, Regulatory Affairs, Advertising and Promotion/Labeling will provide commercial regulatory strategy and direction to enable the business to meet its commercial needs in support of patients and in a compliant manner.Key ResponsibilitiesReview and assess promotional, corporate, and non-promotional materials for compliance with...
-
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewThe Senior Director, Regulatory Affairs, Advertising and Promotion will provide commercial regulatory strategy and direction to enable the business to meet its commercial needs in support of patients and in a compliant manner.Key ResponsibilitiesRegulatory Compliance: Review of promotional, corporate, and other non-promotional materials to assess...
-
Regulatory Labeling Director
4 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation is seeking a highly skilled Regulatory Labeling Director to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global labeling strategies to ensure compliance with regulatory requirements.Key ResponsibilitiesDevelop and maintain global...
-
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation seeks a Senior Director, Regulatory Affairs, Advertising and Promotion to provide commercial regulatory strategy and direction. This role is responsible for ensuring marketing and promotional activities comply with applicable regulations and guidance documents. Key responsibilities include reviewing...
-
Director of Medical Affairs Analytics
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Full timeJob Title: Director of Medical Affairs AnalyticsMadrigal Pharmaceuticals is seeking a highly skilled Director of Medical Affairs Analytics to join our team. As a key member of our Medical Affairs department, you will be responsible for guiding and enhancing the analytics capabilities to drive data-driven decision-making and optimize performance.Key...
-
Director of Preclinical Toxicology and ADME
10 hours ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Full timeJob Title: Director of Preclinical Toxicology and ADMEWe are seeking a highly experienced and motivated Director of Preclinical Toxicology & ADME to lead our dynamic team in driving the preclinical drug development process. This leadership role will be instrumental in designing, executing, and interpreting preclinical studies, focusing on preclinical...
-
Director of Preclinical Toxicology and ADME
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Full timeJob Title: Director of Preclinical Toxicology and ADMEWe are seeking a highly experienced and motivated Director of Preclinical Toxicology & ADME to join our dynamic team at Madrigal Pharmaceuticals. This leadership role will be instrumental in driving the preclinical drug development process, focusing on preclinical candidate toxicology as well as on the...
-
Director of Preclinical Toxicology and ADME
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation is seeking a highly experienced and motivated Director of Preclinical Toxicology and ADME to join our dynamic team. This leadership role will be instrumental in driving the preclinical drug development process, focusing on preclinical candidate toxicology as well as on the absorption, distribution, metabolism,...
-
Director of Preclinical Toxicology and ADME
4 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation is seeking a highly experienced and skilled Director of Preclinical Toxicology and ADME to lead our preclinical drug development process. This leadership role will be instrumental in driving the preclinical candidate toxicology and ADME properties of new drug candidates.Key ResponsibilitiesLead and manage the...
-
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation is seeking a highly skilled Senior Product Manager/Associate Director to lead our HCP Marketing efforts. As a key member of our US Marketing team, you will be responsible for developing and executing best-in-industry HCP marketing strategies to support the commercial launch and growth of our flagship product,...
-
Medical IT Systems Analyst
2 days ago
Conshohocken, Pennsylvania, United States Tandym Group Full timeMedical IT Systems AnalystA leading pharmaceutical company in Pennsylvania is seeking a skilled Medical IT Systems Analyst to join their Medical Affairs team in the Greater Philadelphia area on a contract basis.Key Responsibilities:Ensure the smooth operation and optimization of Veeva CRM implementations tailored to Medical Affairs activities.Manage user...
-
IT Director
2 days ago
Conshohocken, Pennsylvania, United States Pitcairn Trust Company, LLC Full time{"h1": "IT Director Job Description", "p": "Pitcairn Trust Company, LLC is seeking an experienced IT Director to oversee the organization\u2019s Information Technology infrastructure, operations, and information security. The successful candidate will be responsible for aligning technology initiatives with business objectives, ensuring the reliability,...
-
Director of Supply Chain Procurement
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Full timeJob Title: Director / Sr. Director, Supply Chain ProcurementMadrigal Pharmaceuticals is seeking a seasoned procurement leader to join our team as Director / Sr. Director, Supply Chain Procurement. This role will be responsible for developing and executing comprehensive procurement strategies for contract manufacturing-related categories, including raw...
-
IT Director of Research and Development
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation is seeking an experienced IT Executive Director to lead the strategic direction and management of Information Technology initiatives within the Research & Development (R&D), Chemistry Manufacturing and Controls (CMC), and Quality functions of our pharmaceutical operation.Key ResponsibilitiesStrategic...
-
Data and Analytics Director
3 weeks ago
Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation is seeking a highly skilled Data and Analytics Director to lead the design, development, and implementation of advanced analytics solutions that drive business growth and innovation. As a key member of the data strategy team, you will play a critical role in shaping our data architecture and capabilities to...
