Manager, Global Regulatory Strategy

Sarepta Therapeutics; New Jersey; Ibrido; USD 116.000 - 145.000; Tempo pieno

Descrizione del lavoro

Sarepta Therapeutics seeks a Regulatory Affairs professional to lead clinical trial regulatory activities, coordinate submissions, and shape regulatory strategy for assigned markets in a US-based hybrid role.

The candidate will work with cross-functional teams to ensure timely, compliant regulatory submissions and ongoing lifecycle support across Sarepta’s portfolio.

Competenze

• Knowledge of drug development and regulatory process.
• ICH guidelines, IND/CTA, IMPDs, Orphan drug designation.
• Adaptive communication skills (interpersonal, written, verbal).
• Ability to multi-task, prioritize, manage projects and organize complex information.

Mansioni

• Acts as the regulatory affairs clinical lead for clinical trial activities, including planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Questionnaires, label review, etc.
• Reviews regulatory agency submission materials for submissions conducted by a CRO for Sarepta.
• Implements regulatory activities in support of product lifecycle activities for assigned markets.
• Ensures effective assembly and preparation of country-specific submissions.
• Provides regulatory guidance and inputs into project teams via Global Regulatory Teams.
• Contributes to global regulatory strategy and execution.

Conoscenze

Regulatory strategy

Submission planning

Cross-functional collaboration

Project/timeline management

Communication skills

Regulatory knowledge

Analytical thinking

Attention to detail

Formazione

BS or equivalent with 5+ years of relevant experience

MS in Regulatory Affairs or RAC

Strumenti

Microsoft Word

Microsoft Excel

Outlook

Adobe Suite

Descrizione del lavoro

Why Sarepta? Why Now?

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne Muscular Dystrophy and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our next-generation siRNA platform is focused on chronically administered therapies for neurodegenerative and pulmonary diseases.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products' clinical trial and registration and activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs and markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains and develops knowledge of assigned market regulatory procedures. Builds/maintains relationships within GRA & other stakeholders to support effective communication & efficient implementation of regulatory activities for assigned markets & activities.

This is a US based remote position.

The Opportunity to Make a Difference

• Acts as the regulatory affairs clinical lead for clinical trial activities, including but not limited to planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Questionnaires, label review, etc.
• Reviews of all regulatory agency submission materials for submissions conducted by a CRO on behalf of Sarepta
• Implements regulatory activities in support of product lifecycle activities for assigned markets
• Ensures effective assembly & preparation of country specific submissions
• Provides regulatory support to Global Regulatory Lead in definition & communication of regulatory strategy for assigned markets for assigned products & inputs into project teams via GRT, in support of GRA goals
• Contributes to global regulatory strategy and execution and participates in Global Regulatory Teams
• Works closely with RA CRO to maintain trial progression and compliance
• Provides regulatory guidance, in relation to clinical trial activity, and updates cross- functionally as needed
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
• Develops and maintains knowledge of relevant evolving regulation and guidance
• Works on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends
• Escalates and effectively communicates issues to supervisor and other relevant RA stakeholders
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions
• Works on objectives that have meaningful impact on unit and the organization
• Erroneous decisions or failure to execute has medium impact to overall GRA deliverables

More About You

Skills and Competencies

• Knowledge of drug development and regulatory process
• Knowledge of ICH guidelines, IND/ CTA, IMPDs, Orphan drug designation
• Demonstrated experience preparing submissions, with and a clear understanding of submission content and format requirements
• Adaptive communication skills (including interpersonal, written, verbal)
• Ability to successfully multi-task, prioritize, manage projects/timelines, and organize/track complex information
• Experience working in cross functional project teams
• Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and Adobe Suite systems

Education and Experience

• BS or equivalent with 5+ years of relevant experience
• MS in Regulatory Affairs or RAC

What Now?

We're always looking for solution-oriented, critical thinkers.

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $116,000 - $145,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.