Global Regulatory Strategy Lead – Remote

Sarepta Therapeutics; Washington (District of Columbia); Ibrido; USD 116.000 - 145.000; Tempo pieno

Descrizione del lavoro

Sarepta Therapeutics seeks a Regulatory Affairs lead to guide cross-functional teams through clinical trial submissions and regulatory strategy in the United States. You will oversee CTAs, agency interactions, and country-specific submissions, ensuring compliance and timely delivery.

The role is hybrid/remote in the U.S., with competitive salary commensurate with experience and a comprehensive benefits package.

Competenze

• Knowledge of drug development and regulatory processes.
• Understanding of ICH guidelines, IND/CTA, IMPDs, and Orphan drug designations.
• Proven experience preparing submissions with clear formats.
• Adaptive communication across stakeholders and functions.
• Ability to multi-task, prioritize, and manage timelines.
• Experience in cross-functional project teams and accountability.
• Strong command of MS Office applications.

Mansioni

• Lead regulatory affairs activities for clinical trials, including CTAs, agency queries, and labeling reviews.
• Review regulatory submissions prepared by CROs and ensure quality and timeliness.
• Implement regulatory activities supporting product lifecycle plans across markets.
• Prepare country-specific submissions and coordinate with Global Regulatory Teams.
• Provide guidance to cross-functional teams and maintain regulatory knowledge base.

Conoscenze

Knowledge of drug development andRegul

ICH guidelines and IND/CTA/IMPDs

Experience preparing submissions

Adaptive communication skills

Multi-tasking and project management

Cross-functional collaboration

Accountability and ethics

MS Office proficiency

Formazione

BS or equivalent with 5+ years experience

MS in Regulatory Affairs or RAC

Descrizione del lavoro

Sarepta Therapeutics seeks a Regulatory Affairs lead to guide cross-functional teams through clinical trial submissions and regulatory strategy in the United States. You will oversee CTAs, agency interactions, and country-specific submissions, ensuring compliance and timely delivery.

The role is hybrid/remote in the U.S., with competitive salary commensurate with experience and a comprehensive benefits package.