Senior Manager, Regulatory Affairs Device

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 132,000 - 165,000; Full time

Job summary

An established industry player in genetic medicine is seeking a skilled regulatory affairs professional to contribute to the development of innovative therapies. This role involves leading regulatory strategies for clinical trials, ensuring compliance with global regulations, and preparing high-quality documentation for submissions. The ideal candidate will possess extensive experience in regulatory affairs, project management, and cross-functional collaboration. Join a dynamic team that values integrity, accountability, and the drive to make a significant impact on patients' lives. If you are a solution-oriented thinker ready to embrace challenges, this opportunity is perfect for you.

Benefits

Comprehensive Benefits

Work-Life Resources

Financial Wellness Support

Physical and Emotional Wellness Programs

Support for Caregivers

Qualifications

• 8+ years of relevant experience in regulatory affairs.
• Experience with drug/device combination products and clinical studies.

Responsibilities

• Prepare regulatory submissions and correspondence with authorities.
• Manage regulatory activities for submissions to agencies.
• Ensure compliance with documentation management and record keeping.

Skills

Regulatory Strategy Development

Project Management

Cross-Functional Team Collaboration

Communication Skills

Knowledge of ICH Guidelines

Process Improvement

Submission Content Understanding

Education

Bachelor's Degree or Equivalent

Tools

Microsoft Office Applications

Regulatory Systems

Job description

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

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: Sarepta Benefits

The Importance of the Role

Contributes to regulatory strategic discussion and implementation of global regulatory strategies for investigational devices/Companion Diagnostics (CDx)/Combination Products to support business objectives. Supports product registrations and acts as the regulatory affairs lead for clinical trial activities for multiple programs. Contributes to the development of high-quality documentation (e.g., IDEs, IVDR technical documents, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further develops knowledge of assigned market regulatory procedures.

The Opportunity to Make a Difference

• Prepares regulatory submissions and correspondence with regulatory authorities, including IDE, SRD, Q-subs, EU Technical Files, etc.
• Coordinates and manages regulatory activities required for submissions to regulatory agencies for assigned products.
• Works with diagnostic partners to mutually align on co-development regulatory needs and determine regulatory paths toward development and global registration activities.
• Engage internal and external stakeholders to define and implement process improvements as needed.
• Contributes to developing regulatory strategies for assigned projects while accurately interpreting and reflecting regulatory and Corporate guidelines.
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs.
• Supports inspection readiness.
• Maintains/further develops knowledge of relevant evolving regulation and guidance.
• Contributes to global regulatory strategy and execution and participate in Global Regulatory Teams (GRTs).

Impact and Scope

• Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends.
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
• Works on objectives that have major impact on functional area and the organization.
• Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

More about You

• BS or equivalent with 8+ years relevant experience.
• Experience working in GRTs and cross-functional teams.
• Knowledge of drug development, ICH guidelines and device or drug/device combination product regulatory framework.
• Experience working on clinical studies for device, drug or drug/device combination products.
• Demonstrated experience with and a clear understanding of submission content and format requirements.
• Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders.
• Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority.
• Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details.
• Ability to evaluate and recommend process improvement and suggest/implement best practices.
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory systems.

What Now?

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

So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Remote #LI-CM1 This position is remote. However, 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 $132,000 - $165,000 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.