Sarepta Therapeutics
Senior Associate, CMC Regulatory
This job is now closed
Job Description
- Req#: R-02298
Employer Industry: Pharmaceutical Industry
Why Consider this Job Opportunity:
- Salary up to $110,000
- Opportunity for career advancement and growth within the organization
- Remote work opportunity with occasional on-site work at Sarepta facilities and company events
- Competitive compensation and benefits package
- Chance to work on impactful projects in Chemistry, Manufacturing, and Controls Regulatory Affairs
- Supportive work environment with opportunities to collaborate with various stakeholders
What to Expect (Job Responsibilities):
- Provide support on projects including change control regulatory assessments and maintenance of regulatory tracking activities
- Maintain the regulatory CMC health authority questions database
- Support regulatory activities for assigned products, including product lifecycle management
- Coordinate the review and approval of submission documents to ensure regulatory compliance
- Ensure documentation management and record keeping align with regulatory expectations and company SOPs
What is Required (Qualifications):
- Excellent organizational and planning abilities
- Strong communication skills in English, both written and verbal
- Knowledge of global pharmaceutical regulations and guidelines
- Experience working in cross-functional project teams
- Bachelor's degree or equivalent with 3-6 years of relevant experience
How to Stand Out (Preferred Qualifications):
- Experience in Veeva systems
- Ability to quickly adapt to internal regulatory systems
- Proficiency in Microsoft Office Suite and Adobe Acrobat
- Strong understanding of the drug development process
- Presentation and negotiation skills
#PharmaceuticalIndustry #RegulatoryAffairs #CareerGrowth #RemoteWorkOpportunity #CompetitiveSalary
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Sarepta Therapeutics, Inc. is a medical research and drug development company with corporate offices and research facilities in Cambridge, Massachusetts, United States.
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