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Associate Director, Regulatory Affairs (Remote)
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Job Description
- Req#: 33812798525
Employer Industry: Biopharmaceuticals
Why consider this job opportunity:
- Salary up to $228,000
- Opportunity for discretionary annual cash bonuses or incentive compensation
- Comprehensive benefits package including medical, dental, and vision insurance
- 401k retirement savings plan with company contributions
- Flexible paid vacation policy
- Engage in innovative research and development in oncology and neuroscience
What to Expect (Job Responsibilities):
- Develop and implement regulatory strategies to advance programs in all development phases
- Serve as the Regulatory Affairs representative on project teams, providing direction and solutions
- Lead regulatory interactions with health authorities, marketing partners, and vendors
- Review and approve labeling for the company's products
- Ensure timely submission of INDs, NDAs, amendments, and supplements for products/projects
What is Required (Qualifications):
- Minimum of 8 years in regulatory affairs or related areas in pharmaceutical drug development
- Deep knowledge of regulatory affairs and experience with pharmaceutical regulatory submissions
- Proven track record of collaboration with regulatory agencies, including FDA, EMA, and PMDA
- Excellent verbal and written communication skills
- Ability to work with limited supervision, set priorities, and motivate others
How to Stand Out (Preferred Qualifications):
- Masters or advanced degree in a scientific discipline
#Biopharmaceuticals #RegulatoryAffairs #CareerOpportunity #CompetitivePay #InnovativeResearch
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