- Responsible for preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption (IDE) applications. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Working with diagnostic partners to mutually align on co-development regulatory needs and determine regulatory paths toward development and global registration activities
- Responsible for or contributes to proactively formulating regulatory strategies that provide a streamlined development and approval timeline while accurately interpreting and reflecting regulatory and corporate guidelines. Plans and manages integration of multi-disciplinary regulatory programs into the project team development plans for all assigned projects
- Represents Sarepta at FDA and EMA agencies for all assigned products. Oversees the planning and conduct of meetings with regulatory agencies as appropriate
- Initiates and responds to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products
- Provides Sarepta with current and proposed regulatory, scientific, and pertinent legal issues (i.e., external meetings, workshops, and conferences)
- Ensures that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
- Guides project teams to implement appropriate regulatory strategies
- Supervises and coordinates all regulatory activities required for submissions to regulatory agencies for assigned products
- Leads Global Regulatory Team(s)
- Contributes to, with the ability to own, SOPs and internal regulatory quality procedures
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
- Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements.
- Works on objectives that have critical impact on functional area and the organization
- Erroneous decisions or failure to achieve results will add to costs, result in critical delay(s) and may have serious impact on the overall success of functional, division, or company operations
- In depth experience in device or drug/device combination product regulatory framework, global experience is preferred
- Detailed knowledge of product labeling for devices
- Demonstrated knowledge of drug development process
- Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience
- Experience with preparing regulatory submissions and briefing packages for regulatory meetings
- Personal leadership, with an ability to bring divergent views together, agree on common objectives and engender enthusiasm even in challenging circumstances
- Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally at all levels within the organization
- Solid sense of accountability, sound judgement and decision-making skills, and strong attention to detail
- BS or equivalent with 12+ years of related experience
- Prior regulatory affairs experience in major markets is expected
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Director, CMC Regulatory Affairs - Cambridge, United States - Sarepta Therapeutics
Description
Lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs). Positively contributes to the global regulatory strategy for clinical and commercial therapeutic programs, Facilitate identification and resolution of scientific and regulatory issues with the regulatory agencies. Directs the preparation and submission of IVD/CDx global submissions. Management or leadership of junior regulatory personnel. Manages contractual and budgetary responsibilities with best business practices. Remains current with evolving regulation and guidance for integrated review of guidance to develop strategies.
Primary Responsibilities Include:
#LI-Remote
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 $180,000 - $225,000 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.
