PRA Health Sciences
Regulatory Project Manager - East Coast
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Job Description
- Req#: 121707
Employer Industry: Clinical Research and Healthcare Intelligence
Why consider this job opportunity:
- Competitive salary and benefits package
- Opportunity for career advancement and growth within the organization
- Flexible country-specific optional benefits, including childcare vouchers and discounted gym memberships
- Supportive and inclusive work environment that values diversity
- Access to a global network of health professionals through the Global Employee Assistance Programme
What to Expect (Job Responsibilities):
- Collaborate with regional and global cross-functional teams to plan and deliver compliant regulatory submissions
- Create and manage project plans for regulatory projects, incorporating input from key stakeholders
- Lead and manage cross-functional submission teams from authoring to project goal delivery
- Identify operational risks and implement mitigation plans for regulatory projects and submissions
- Communicate external agency submission standards and internal processes to ensure compliance and efficiency
What is Required (Qualifications):
- At least 5+ years of relevant experience in submissions, regulatory operations, or publishing
- Strong project management skills, with proficiency in Microsoft Project
- Relevant educational background, such as a BA or higher in a life sciences discipline
- Experience in BLA submission
- Familiarity with OnePager and Planisware is a plus
How to Stand Out (Preferred Qualifications):
- Previous experience in managing global regulatory submissions
- Proven track record in leading cross-functional teams effectively
- Knowledge of current regulatory guidelines and compliance requirements
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
#ClinicalResearch #RegulatoryAffairs #ProjectManagement #HealthcareCareers #DiversityandInclusion
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