Manager, Regulatory Affairs

Summary of Duties and Responsibilities

Develops and implements regulatory strategies for all phases of 505(b)(2) NDA and ANDA product development, from product pipeline evaluation to post-approval commercial support.

Key Responsibilities

• Function as liaison with health authorities, including providing complete and timely responses to health authority requests for information, and representing company in Pre-IND, Pre-NDA, and other FDA meetings
• Develop and implement integrated regulatory plans that deliver against strategic objectives, and maintain compliance
• Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
• Manage internal review/approval process for CMC related submissions and regulatory questions;
• Write and submit FDA submissions (i.e. 505(b)(2) NDA, ANDA, pre-submissions, PAS, annual report, CBE-0, CBE-30)

Qualifications

• Bachelors degree in life sciences, chemistry or related discipline, advanced degree preferred
• 5 years of experience, including hands-on regulatory affairs and successful 505(b)(2) NDA and ANDA submission experience
• Experience with FDA/US regulatory submissions
• Demonstrated excellence in regulatory liaison/strategy
• Strong written and verbal communication skills
• Able to work independently and in a team setting
• Able to travel for meetings with corporate partners and regulatory authorities

Job Type: Full-time

Pay: $20.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• FDA regulations: 5 years (Preferred)

Work Location: One location