Regulatory Affairs Director

1 week ago


Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Full time
Job Summary

Madrigal Pharmaceuticals is seeking a highly experienced Regulatory Affairs Director to lead our regulatory strategy and ensure compliance with global regulations. As a key member of our team, you will be responsible for managing the day-to-day regulatory activities of assigned projects, developing and planning regulatory submission strategies, and coordinating the preparation of submissions to regulatory agencies.

Key Responsibilities:
  • Act as the regulatory representative on core teams and develop regulatory submission strategies.
  • Coordinate the preparation of submissions to regulatory agencies and conduct regulatory intelligence activities.
  • Participate on Project Teams in the development, creation, and implementation of regulatory and development products.
  • Provide regulatory guidance and compliance oversight for regulated products.
  • Interface with various departments within R&D, Commercial, and other applicable groups to develop and execute viable Regulatory Strategies.

Qualifications:
  • BS in life sciences in a healthcare field or equivalent experience.
  • Advanced degree strongly preferred.
  • Minimum 10 years branded regulatory pharmaceutical drug development experience.
  • Broad based therapeutic area and product experience.
  • Strategic regulatory affairs experience with a proven track record in new chemical entity and line extension regulatory filings, approvals, and strategic planning.

What We Offer:
  • Base salary determined by qualifications, skills, education, experience, business needs, and market demands.
  • Eligible for bonus, equity, and comprehensive benefits, including flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job SummaryMadrigal Pharmaceuticals Corporation seeks a highly skilled Regulatory Affairs Director to lead our regulatory strategy and ensure compliance with global regulations. The ideal candidate will have a strong background in pharmaceutical drug development and a proven track record in regulatory affairs.Key Responsibilities:Develop and implement...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job 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 leadership team, you will be responsible for ensuring that our organization remains compliant with all relevant regulatory requirements.Key Responsibilities:Develop and implement...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job 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...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job 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...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job SummaryThe Director of Regulatory Affairs will oversee all regulatory matters, ensuring compliance with FDA and state requirements, AATB Standards, and other applicable regulations. This role will be responsible for creating and implementing regulatory strategies, supporting organizational strategic objectives, and directing internal audit programs.Key...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job Summary:The Director of Regulatory Affairs will oversee all regulatory matters, ensuring compliance with FDA and state requirements, AATB Standards, and other applicable regulations. This role will create and implement regulatory strategies, support organizational objectives, and direct internal audit programs.Key Responsibilities:Develop and implement...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job 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,...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job 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 Inc Full time

    The Senior Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the business to meet its commercial needs in support of patients and in a compliant manner.Responsibilities pertain to marketing and promotional activities focused on Madrigal's lead candidate, resmetirom, a...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job 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...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job Title: Regulatory Labeling DirectorJob Summary:We are seeking a highly skilled Regulatory Labeling Director to join our team at Madrigal Pharmaceuticals Corporation. As a key member of our regulatory team, you will be responsible for providing regulatory expertise to drug development teams on the development and submission of labeling components for...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Full time

    Job 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...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job 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,...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Inc Full time

    bJobSummary/bbrbrTheSeniorDirectorofRegulatoryAffairsforAdvertisingandPromotionwillprovidecommercialregulatorystrategyanddirectiontoenablethebusinesstomeetitscommercialneedsinsupportofpatientsandinacompliantmanner.Thisroleisresponsibleforreviewingpromotional,corporate,andothernon-promotionalmaterialstoassessforcompliancewithapplicableregulations,guidancedocu...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job 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,...


  • Conshohocken, Pennsylvania, United States Tandym Group Full time

    Medical 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 weeks 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,...

  • Tax Director

    1 week ago


    Conshohocken, Pennsylvania, United States Pitcairn Trust Company, LLC Full time

    Job Title: Director of TaxPitcairn Trust Company, LLC is seeking a highly skilled and experienced Director of Tax to join our team. As a key member of our tax function, you will be responsible for developing and implementing innovative tax strategies for our ultra-high-net-worth clients.Key Responsibilities:Develop and implement tax strategies tailored to...


  • Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

    Job 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...


  • Conshohocken, Pennsylvania, United States Jobot Full time

    Jobot is looking for a Junior Corporate Paralegal with Transactional ExpertiseA prominent financial organization is in search of a Junior Corporate Paralegal to enhance their legal team. The successful candidate will possess experience in preparing documentation for mergers and acquisitions, fund transactions, vendor contracts, regulatory filings, limited...