Handa’s mission is to develop high-quality prescription medications, including proprietary therapeutics that address significant unmet patient needs, as well as to ensure access to high-barrier-to-entry generic drugs.
Handa is dedicated to providing a positive, team-oriented environment where colleagues may learn, grow and develop themselves. We welcome inquiries from all master’s or doctorate degree holders with medical, pharmaceutical, biotechnology or chemistry backgrounds, who recognize our vision, hold a positive attitude and are committed towards learning and teamwork.
We currently have the following openings.
(1)Job Title: Director, 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 production.
- 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;
- Prepare and submit FDA submissions (i.e. 505(b)(2), Pre-Sub, ANDA, PAS, annual report, CBE-0, CBE-30, etc.)
- Bachelor degree in life sciences, chemistry or related discipline, advanced degree preferred
- 5-10 years of experience including hands-on regulatory affairs and successful 505(b)(2) NDA and ANDA submission experience
- Oncology experience strongly preferred
- Experience with FDA/US regulatory submissions
- Demonstrated excellence in regulatory liaison/strategy
- Able to travel for meetings with corporate partners and regulatory authorities
(2)Job Title: Manager, Product Development
Summary of Duties and Responsibilities
Plan and perform various stages of product development, including pre-formulation, formulation development, process development, optimization, scale-up studies/technology transfer for both immediate- and modified-release 505(b)(2) and generic solid oral and alternate dosage products
- Perform literature and patent search to support studies for development of drug products and generate data/development reports as part of regulatory submissions or patent filings
- Designs quality scientific experimentation independently to develop robust formulations and processes. Implements QbD, risk assessments, and process capability with DOE and statistical/data analysis. Makes sound scientific conclusions
- Provides guidance to R&D scientists (Hangzhou and Taiwan) to execute formulation and process development experimentation and summarize the results in the presentation slides and reports
- Write and review GMP documentation, including manufacturing batch records, and appropriate study protocols
- Evaluates and selects the contract manufacturing organizations (CMOs)
- Supports collaboration with CMOs to manufactures pilot/pivotal, clinical, stability, scale-up, and demo batches to support regulatory filings, process optimizations, and technology transfers; conducts investigations for deviations and ensures proper correction actions are taken and effective
- Prepares CMC documents for 505(b)(2) NDA and ANDA submissions, responses for deficiency letters, and product development reports, represents Product Development and acts as subject matter expert with government agencies, e.g. FDA/CFDA during Pre-Approval Inspection or in responding to deficiencies to submitted applications
- Trains personnel in job functions.
- PhD. in Pharmaceutics, Chemistry, Chemical Engineering, or related discipline, with 5+ years of experience, or Master’s with equivalent experience
- In depth knowledge of theory and techniques in pharmaceutics and drug delivery
- Solid knowledge in product development and manufacturing per cGMP compliant procedures, as well as for IND and NDA
- Hands on experience in product development including solution, suspension, and/or semisolid products.
- Strong written and verbal communication and presentation skills
- Self-motivated with the ability to work independently with minimal supervision
- Ability to travel
- Fluent in Chinese and English
If you are interested in joining Handa, please e-mail your resume to email@example.com.