This company is developing and commercializing novel therapeutics for the treatment of nonalcoholic steatohepatitis (NASH). They are seeking a Director Regulatory Labeling to support their commercial and clinical programs. Reporting into the SVP of Regulatory, you will be responsible for Labeling Strategy, Labeling Operations and Labeling Compliance. This company offers a collaborative, patient-focused culture and hybrid working arrangements. With one approved product and a strong cash position, now is an exciting time to join this rapidly growing organization.
Responsibilities:
Global Labeling Strategy
- Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
- Control the consistency of labeling through review of content across the product family.
- Identify areas of potential non-compliance and supports investigations as needed. Escalate 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.
- Identify potential non-compliance and supports investigations as needed.
- Lead and facilitate the global/regional labeling working groups to support the development of core and major regional labeling.
Global Labeling Compliance
- Track compliance with established processes. Provide compliance data to department management, internal and external clients.
- Write and track Corrective and Preventative Actions (CAPAs). Tracks and compiles department metrics.
United States (US) Labeling Operations
- Provide regulatory expertise and guidance for the development and submission of US labeling components. Control the consistency of US labeling content through alignment with the core documents across product families and with all applicable best practices.
- Manage FDA-required Structured Product Labeling (SPL) documents.
- Create and provide lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork). Provide regulatory review and acts as text approver through alignment between approved content and artwork.
- Coordinate US labeling submission, approval and implementation activities through internal or client, systems and processes.
- Provide 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.
Europe (EU) Labeling Operations
- Provide regulatory expertise to regulatory teams on the development and submission of European labeling components for Health Authority review. Support the consistency of European labeling through review of content in alignment with the core documents across product families.
- Manage and coordinate EU SmPC updates (contributors, systems, approvers etc.). Ensure that PI adheres to regulatory template/format of EU SmPC and provides subject matter expertise on associated guidelines and guidance documents.
- Manage translations, linguistic review process, and readability activities.
Knowledge and Skills:
- A minimum of 10 years required of Regulatory Affairs experience with a minimum of 8 years in Regulatory Labeling.
- Bachelors degree required. Advanced degree (MS, PhD, or PharmD) preferred.
- US and EU labeling expertise required. International and Core Labeling experience preferred.
- Experience negotiating with internal and external stakeholders on complex regulatory issues.
- Thorough understanding of regulatory labeling requirements and strategic labeling planning.
- Must have experience driving the development of CCDS and TPPs.
- Experience integrating themselves in managing labeling meetings
- History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
- Strong interpersonal skills, including conflict management and negotiation skills.
- Outstanding interpersonal and communication (written and verbal) skills.
- Willing to roll up sleeves and do whatever is needed to ensure Regulatory success.
- Must be comfortable with ambiguity in a small company environment
This company has offices in the Greater Philadelphia area and in the Boston area. The Labeling Director must be onsite three days a week in one of these locations.
The budgeted salary range for this position is US$200,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.