Responsible to oversee Regulatory Affairs department to be in compliance with FDA and other federal, state and local regulation on facilities/products registration, air and water pollution, waste water disposal, and chemical releases; deals with regulatory agencies, develops compliance strategies, directs related training effort.
The Regulatory Affairs Manager falls under the Research and Development Division in the organizational chart, reporting directly to the Director of Research and Development.
Major Functional Objectives:
- Manage and oversee regulatory affairs department.
- Create and implement an external regulatory advisory service.
- Increase our regulatory advisory capabilities.
- To Contact and liaison with local, state and federal regulatory agencies for facilities and products licensing, registration, and recall.
- To establish and maintain Facility registration product submission packages, supplements, annual reports, drug listing, licensing, and others.
- To review and provide final approval to label design and other related publications to ensure compliance with codes or guidelines required by regulatory agencies.
- To coordinate with contract laboratory for clinical studies to support product development and for product submission.
- To prepare and review regulatory documents submission such as annual report, CBE-30, and new ANDA submission.
- To assist in maintaining department budget and process purchase requisition and cash requisition.
- To Act as project coordinator to conduct product sourcing, screening, scheduling of
- Product Research and development and registration and licensing, and maintains related records, files, list of existing products and products under development or consideration.To investigate and adjust customer complaints regarding quality. May assist in training activities
- To complete assist new projects assigned by upper management team
- Performs other duties, as assigned.
- MS office proficiency
- Strong typing skills
- Good verbal and written skills
- Chinese speaking and writing is a plus
Education and/or relevant experience:
- Bachelor’s degree in science or relevant related field
- Minimum of 10 years of industry experience with increasing responsibilities
- Minimum of 5 years as regulatory manager in pharmaceutical drug development
Management & Organizational Challenges:
- Quality mindset with a focus of strong consistent practices in cGMP.
- Partnering, communicating and working with other departments.
Environment / Culture:
- Fast-paced, very dynamic environment with expectation of multi-tasking and accomplishing tasks in a timely manner.
- Self-Driven by continuous improvement
- Detailed oriented.