Senior Associate Regulatory Strategy
Senior Associate Regulatory Strategy
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$ 92000 - 115000
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
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. Completion of work must be in compliance with SOPs and GRA best practices.The Opportunity to Make a Difference
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 coordination of the review & approval of submission documents as required to ensure regulatory compliance
More about You
- BS or equivalent with 36 years of relevant experience
- Works on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Follows the advice of more senior team members to resolve technical and planning problems
- Works on objectives that support department goals rather than as a key contributor to corporate goals
- Erroneous decisions or failure to execute has medium impact to overall GRA deliverables
- 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
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 IC
Employment Type
Full-Time
