Madrigalpharma
Senior Director, Regulatory Affairs, Advertising and Promotion
Madrigalpharma, Conshohocken, Pennsylvania, United States, 19428
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 once daily, oral, thyroid hormone receptor (THR)-β selective agonist that is designed to target key underlying causes of NASH in the liver.
Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.
Key Responsibilities:
Review promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.Represent the commercial regulatory perspective at and chair the promotional review committee (PRC) which includes cross-functional partners from Marketing, Medical Affairs, and Legal/Compliance.Lead and manage all necessary regulatory operational needs such as enhancements to internal systems, subpart H pre-clearance submissions, and Form 2253 submissions.Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.Serve as internal expert on FDA regulations governing the promotion of Madrigal products.Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP).Manage interaction with OPDP including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP staff.Participate in company working groups on advertising and promotion standards and guidelines.Accountable for the oversight and compliance of product artwork.Responsible for the development and maintenance of the product labeling in collaboration with internal stakeholders.Partner with internal stakeholders to develop and maintain the Core Company Data Sheet.Contribute to applicable regulatory strategies for all projects with impact to labeling.Develop and lead all applicable internal committees and the associated processes with respect to approvals of labeling changes.Provide support and contribute to Regulatory intelligence and Regulatory policy with focus on labeling; and when necessary, conduct detailed analyses.Qualifications:
Requires a BA/BS degree in a scientific discipline and advanced scientific degree preferred.10-12+ years of Pharmaceutical/Biotech industry experience and 6-8+ years’ experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents, including significant Subpart H and/or Subpart E experience.Excellent verbal and written communication skills and interpersonal skills are desired.Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.
Key Responsibilities:
Review promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.Represent the commercial regulatory perspective at and chair the promotional review committee (PRC) which includes cross-functional partners from Marketing, Medical Affairs, and Legal/Compliance.Lead and manage all necessary regulatory operational needs such as enhancements to internal systems, subpart H pre-clearance submissions, and Form 2253 submissions.Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.Serve as internal expert on FDA regulations governing the promotion of Madrigal products.Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP).Manage interaction with OPDP including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP staff.Participate in company working groups on advertising and promotion standards and guidelines.Accountable for the oversight and compliance of product artwork.Responsible for the development and maintenance of the product labeling in collaboration with internal stakeholders.Partner with internal stakeholders to develop and maintain the Core Company Data Sheet.Contribute to applicable regulatory strategies for all projects with impact to labeling.Develop and lead all applicable internal committees and the associated processes with respect to approvals of labeling changes.Provide support and contribute to Regulatory intelligence and Regulatory policy with focus on labeling; and when necessary, conduct detailed analyses.Qualifications:
Requires a BA/BS degree in a scientific discipline and advanced scientific degree preferred.10-12+ years of Pharmaceutical/Biotech industry experience and 6-8+ years’ experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents, including significant Subpart H and/or Subpart E experience.Excellent verbal and written communication skills and interpersonal skills are desired.Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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