Senior Director, Regulatory Affairs, Advertising and Promotion Lead

4 weeks ago

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 promotional materials, chairing the promotional review committee, and managing regulatory operational needs. The ideal candidate will have 10-12+ years of pharmaceutical industry experience and 6-8+ years of experience as a primary regulatory representative. Excellent communication and negotiation skills are required.

Key Responsibilities:
  • Review of promotional materials for compliance with regulations and guidance documents
  • Chairing the promotional review committee and managing cross-functional partners
  • Managing regulatory operational needs, including subpart H pre-clearance submissions and Form 2253 submissions
  • Providing strategic regulatory guidance on corporate communications and product labeling
  • Serving as an internal expert on FDA regulations governing the promotion of Madrigal products
  • Managing interactions with the Office of Prescription Drug Promotion (OPDP)
  • Participating 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 product labeling
  • Partnering with internal stakeholders to develop and maintain the Core Company Data Sheet
  • Contributing to applicable regulatory strategies for all projects with impact to labeling
  • Developing and leading internal committees and processes for labeling changes
  • Providing support and contributing to Regulatory intelligence and Regulatory policy with focus on labeling


Qualifications:
  • 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
  • Excellent verbal and written communication skills and interpersonal skills
  • Ability to navigate complex regulatory framework and remain solutions-oriented
  • Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations
  • Assumes a leadership role in updating and advising Company stakeholders on changes in regulations and policies


Compensation:

Base salary is determined by several factors, including qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, including 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.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.

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