Senior Director - Regulatory Affairs
July 31
🏡 Remote – New York
Description
• As Sr. Director of Regulatory Affairs you will leverage your experience preparing IND and NDA packages to successfully bring drugs into the clinic and through marketing approval. • You will be part of a diverse team reporting to the Head of Early Development to contribute to our mission of advanced drug discovery by developing a regulatory strategy, including multiple different paths (e.g., 505b1, 505b2, botanical) as well as preparing submission packages for regulatory agencies including FDA, EMA, and TGA (Australia). • The role will require you to use your knowledge in FDA regulations and your creativity to develop strong submissions specifically for FDA pre-meetings and IND submission with unique strategies that take advantage of our platform and assets.
Requirements
• 10+ years in FDA regulatory affairs for the biotechnology and or supplement/cosmetic industry • Exceptional communication, both verbal and written • Experience preparing and submitting FDA meeting request, IND and NDA packages using the eCTD structure. • If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.
Benefits
• Culture: Enveda lives for people • Salary: $260,000 - $290,000 • Equity • Healthcare: Medical, dental and vision insurance. Company pays 90% of premium for employee and dependents • 401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation). • PTO: Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays. • Work-Life Harmony • Adoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.
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