Senior Regulatory Professional
3 weeks ago
The estimated salary for this role is $182,500 per year, based on the job requirements and industry standards. This compensation package includes benefits, bonus, stock options, and other applicable variable compensation.
Job Description- Main Responsibilities:
- Provide regulatory guidance to project teams and key sub-teams at study level
- Assess, develop, and implement competitive global regulatory strategies for ivonescimab
- Own regulatory activities at molecule and study-level, including clinical trial application (CTA) and IND submissions
- Broadly apply regulatory/technical knowledge of government regulations and skills
- Key Skills:
- Strong written, oral communications in English
- Experience interfacing with government regulatory agencies and health authorities
- Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
- Requirements:
- BA/BS degree in the biological or health-related sciences required, graduate-level degree a plus
- Relevant (bio)pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairs
The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits compensation.
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