Job description

Skills Required:

• Extensive Knowledge with 21 CFR, 312 and 314, cGXP’s; FD&C Act – 505(b)(1) & 505(b)(2); FDA Guidance and ICH Guidance
• Demonstrated success in managing the development of new products & filing of Investigational New Drug (INDs) and NDAs including compilation of NDA sections
• Hands on Experience Compiling a 505(b)(2) NDA working with clinical, preclinical, pharmacokinetic, statistics and labeling teams.
• Strong Written and Verbal Communication Skills
• Team player, able to collaborate cross-functionally
• Strong Time Management skills
• Ability to multi-task, and to adjust priorities as needed
• Ability to work independently with a minimum of supervision
• Strong problem solving skills

Responsibilities:

• Lead planning, writing and review of all Regulatory Submission to support Pre-IND/IND/NDA 505(b)2 submissions including FDA meeting requests and packages
• Execution of compilation through submissions.
• Provide regulatory support for the 505(b) (2) products in development, through NDA Approval as well as post -approval life cycle management.
• Critically reviews documentation from clinical/non-clinical developments, R&D, internal & stakeholders, vendors, consultants, Labeling and other appropriate departments.

Job Type: Full-time

Pay: $70,283.88 - $120,078.43 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Please do Provide Expecting Salary/Range ::

Experience:

• NDA: 3 years (Required)
• Pre-IND/IND: 3 years (Required)
• Regulatory Submissions: 3 years (Required)
• Pharmaceutical Regulatory Affairs: 3 years (Required)

Work Location: Remote

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