Senior Manager Regulatory Affairs Device
Senior Manager Regulatory Affairs Device
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$ 132000 - 165000
1 Vacancy
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 limbgirdle 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.
Were 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 worklife 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: 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 products 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 crossfunctionally 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 Qsubs 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 codevelopment 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 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
Were always looking for solutionoriented critical thinkers.
So if youre 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.
Required Experience:
Senior Manager
Employment Type
Full-Time
