Associate Director, Labeling and Disclosures

Sarepta Therapeutics•Cambridge, MA

2d•$160,800 - $201,000•Onsite

About The Position

The Associate Director, Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities for applicable clinical trials. The Associate Director is responsible for the development, maintenance, and harmonization of core labeling (e.g., CCDS) and local labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle objectives. The Associate Director may also oversee the end-to-end operations for clinical trial registration, maintenance and results posting on Health Authority-managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT). The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross-functional study teams, senior management) and external key stakeholders (e.g., vendors, business partners) to ensure business needs and regulatory requirements are met, prioritized, and communicated.

Requirements

BS in related field with 10+ years of related experience
Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.
Candidates must be authorized to work in the U.S.

Nice To Haves

Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations with Health Authorities) and/or Disclosures (e.g., publishing applicable clinical trial registrations and/or results), preferred

Responsibilities

Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products
Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling consistent with reference labeling
Responsive to business goals offering creative and compliant solutions while ensuring company regulatory integrity and consistency in communications and activities
Ensures alignment between reference labeling and regional adaptations while supporting affiliate needs
Collaborates with cross-functional leads on package labeling (artwork) development, updates, and maintenance
Supports Global Regulatory Strategists with HA interaction labeling strategy, including submissions, responses to questions, and negotiations.
May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures, and applicable regulations
Manage process for individual participant data (IPD) report generation at the end of clinical studies and act as point on external IPD requests received through Sarepta's privacy team
Building and maintaining relationships with the Global Regulatory Affairs team, cross functional contributors, and the external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness
Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect
Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
Maintains knowledge of relevant evolving regulation and guidance
Key contributor within Global Regulatory Teams to establish and implement regulatory strategy
Interacts across levels and line functions to lead team through successful engagements with Health Authorities