Director, Regulatory Labeling - Madrigal Pharmaceuticals Corporation
Conshohocken, PA 19428
About the Job
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Key Responsibilities:
Global Labeling Strategy
- Provides regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.
- Identifies areas of potential non-compliance and supports investigations as needed. Escalates issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes. Identifies potential non-compliance and supports investigations as needed.
- Leads and facilitates the global/regional labeling working groups to support the development of core and major regional labeling.
- Tracks compliance with established processes. Provides compliance data to department management, internal and external clients.
- Writes and tracks Corrective and Preventative Actions (CAPAs). Tracks and compiles department metrics.
- Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the core documents across product families and with all applicable best practices.
- Manages FDA-required Structured Product Labeling (SPL) documents.
- Creates and provides lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork). Provides regulatory review and acts as text approver through alignment between approved content and artwork.
- Coordinates US labeling submission, approval and implementation activities through internal or client, systems and processes.
- Provides operational support through the management of change control of labeling documents, creation and maintenance of annual report labeling summary with Final Printed Labeling (FPL), maintenance of current competitor lists and monitoring for updates impacting labeling, and support of labeling implementation tracking.
- Provides regulatory expertise to regulatory teams on the development and submission of European labeling components for Health Authority review. Supports the consistency of European labeling through review of content in alignment with the core documents across product families.
- Manages and coordinates EU SmPC updates (contributors, systems, approvers etc.). Ensures that PI adheres to regulatory template/format of EU SmPC and provides subject matter expertise on associated guidelines and guidance documents.
- Manages translations, linguistic review process, and readability activities.
- BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred. (advanced degree a plus).
- Minimum 10 years branded regulatory pharmaceutical drug development and labeling experience (with FDA, EMA, etc.). Broad based therapeutic area and product experience.
- Demonstrated experience interacting with global health authorities.
- Strong knowledge of regulations/guidelines governing global development of pharmaceuticals and labeling requirements is required.
- Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies regarding labeling.
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.
#LI-Hybrid
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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