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Associate Director, Regulatory Affairs (Remote)
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Job Description
- Req#: 33813277628
Employer Industry: Biopharmaceuticals
Why consider this job opportunity:
- Salary range from $152,000.00 to $228,000.00
- Potential for discretionary annual cash bonuses or incentive compensation
- Competitive benefits package including medical, dental, and vision insurance, 401k retirement savings plan, and flexible paid vacation
- Opportunity for career advancement within a global biopharma company
- Work in a diverse and innovative environment focused on transforming patients' lives
What to Expect (Job Responsibilities):
- Develop and implement regulatory strategies for programs in all phases of development
- Serve as the Regulatory Affairs representative on project teams, providing direction and feedback
- 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 of experience in regulatory affairs or related areas in pharmaceutical drug development
- Deep knowledge of regulatory affairs with direct experience in pharmaceutical regulatory submissions and product approvals
- Proven track record of effective collaboration with regulatory agencies, including FDA, EMA, and PMDA
- Excellent verbal and written communication skills
- Ability to work independently, set priorities, and motivate others
How to Stand Out (Preferred Qualifications):
- Masters or advanced degree in a scientific discipline
#Biopharmaceuticals #RegulatoryAffairs #CareerOpportunity #CompetitivePay #InnovationInHealthcare
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