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Senior Associate – Regulatory Strategy
| Company | Sarepta |
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| Location | Cambridge, MA, USA |
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| Salary | $92000 – $115000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- BS or equivalent with 3-6 years of relevant experience
- Excellent organizational, tracking of tasks and planning ability
- Ability to clearly convey information to peers, supervisors and other internal stakeholders using written and verbal (English)
- Good presentation and negotiation skills, the ability to influence others without authority
- Knowledge of global pharmaceutical regulations and guidelines
- Experience supporting and working with cross functional project teams
- Proficient in Microsoft Office Suite (Outlook, Word, etc.) and Adobe Acrobat
- Ability to quickly become proficient with internal regulatory systems
Responsibilities
- Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs by providing Regulatory Strategy Operational Support to a variety of project teams
- Responsible for completing and tracking of requested activities while in compliance of SOP timelines and/or timelines specified by RA leads
- Actively supports RA project leads with Regulatory activities associated with the preparation and submission of agency questions, periodic submissions, INDs, NDAs and BLAs
- Ensures accurate planning & tracking of activities requested by various project teams
- Ensures completion of entries in internal regulatory systems, effective assembly and preparation of submission dossiers as requested
- With supervision, provides regulatory support for various products, including product lifecycle
- With supervision supports submission owner on preparation of submission core content
- Ensures effective co-ordination of the review & approval of submission documents, as required to ensure regulatory compliance
Preferred Qualifications
No preferred qualifications provided.
