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Specialist, Regulatory Affairs-CMC(Remote)
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Job Description
- Req#: 5543287004
Employer Industry: Biotechnology
Why consider this job opportunity:
- Competitive annual bonus for all full-time employees
- Health, dental, and vision insurance starting on your first day, with 90% of premiums covered for team members and dependents
- 12 weeks of paid parental leave, along with childcare support and dependent care discounts
- Opportunities for professional and personal development resources
- Engaging and collaborative work environment focused on innovative solutions for genetic diseases
- 401(K) company match and a fully-stocked kitchen with free food/drinks
What to Expect (Job Responsibilities):
- Assist in the technical review and preparation of investigational drug, marketing applications, and other formal reports for regulatory submission
- Ensure compliance of documents with established regulatory requirements
- Contribute to the development and implementation of regulatory strategies for assigned projects
- Liaise as the CMC representative across functional groups and client teams to propose strategies and identify potential project delays
- Prepare, coordinate, and maintain regulatory CMC documentation submissions in accordance with applicable regulations
What is Required (Qualifications):
- Bachelor's degree in a scientific discipline or equivalent; advanced degree or Regulatory Affairs Certification preferred
- 2 to 4 years of regulatory experience in the pharmaceutical or biotechnology industry
- Experience in preparing and submitting documents in an eCTD compliant manner
- Solid understanding of FDA regulations and ICH guidance, along with knowledge of the drug development process
- Strong communication skills (oral, written, and interpersonal) with a high level of attention to detail
How to Stand Out (Preferred Qualifications):
- Experience with regulatory submissions in Common Technical Document format
- Ability to handle multiple projects and prioritize effectively
- Proficiency with Microsoft Office applications, Adobe, SharePoint, and document management templates
- Experience with eCTD publishing software
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