Emergent Biosolutions
Specialist, Regulatory Affairs Operations - Remote
This job is now closed
Job Description
- Req#: 36207
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $122,300
- Opportunity for merit increases and annual bonuses
- Comprehensive benefits package, including health and wellness programs
- Collaborative work environment with passionate professionals
- Potential for career advancement within the Global Regulatory Operations Team
- Involvement in significant public health challenges and impactful projects
What to Expect (Job Responsibilities):
- Track and compile regulatory submissions from electronic sources and ensure compliance with established timelines
- Review published submissions prior to filing with Health Authorities
- Collaborate with internal regulatory staff and external vendors to facilitate timely publishing and submission of documents
- Assist in the development and maintenance of document standards and procedures for electronic submissions
- Manage multiple submission publishing jobs effectively while ensuring accuracy and attention to detail
What is Required (Qualifications):
- B.Sc. or B.A. or a college diploma program with specialized training in Regulatory Affairs
- Minimum of 3+ years of experience in publishing global submissions, preferably for biological and vaccine products
- Experience with DocuBridge submission publishing and Veeva document management preferred
- Proficiency in formatting documents in Microsoft Word
- Strong written and verbal communication skills, with the ability to establish professional relationships
How to Stand Out (Preferred Qualifications):
- International publishing experience
- Ability to solve routine problems with minimal supervision
- Technical understanding of data object associations and data flow
- Strong interpersonal skills and careful attention to detail
#Biotechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #PublicHealthImpact
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland.
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