Manager, Regulatory Affairs
Handa Pharma, LLC
San Jose, CA
manager
regulatory
regulatory
health
insurance
authority
meetings
strategy
develops
product development
pipeline
evaluation
ind
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February 22, 2023
Handa Pharma, LLC
San Jose, CA
FULL_TIME
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
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