Responsibilities
- • Oversees the coordination of submissions, and assists with the development of strategy for US and EU submission of new products.
- • Contributes to the development of adequate regulatory strategies.
- • Prepares and/or coordinates the preparation of submission documents.
- • Provides guidance and support to product development teams on regulatory issues.
- • Establishes standard operational procedures to achieve efficiency within regulatory affairs, including the interfacing with other departments.
- • Keeps abreast of changes in the regulatory environment, identifies educational needs, sets up training sessions, and provides information on applicable regulatory topics to involved personnel across the organization.
- • Provides input to the management team in establishing short and long-term business strategic plans and objectives.
- • Creates and reviews abstracts and manuscripts created by internal or external sources.
Experience
- • At least 6 years (Director) or 10 years (Senior Director) in diverse regulatory roles gained working for a pharmaceutical, biotechnology, or CRO company.
- • Deep knowledge of US and EU regulations for biosimilars is preferred.
- • Deep knowledge of regulations for drugs and biologics.
- • Extensive familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
- • Experience in various regulatory submissions and communication with regulatory agencies.
- • Experience in working in multi-culture/multi-countries environment is preferred.
Skills
- • Demonstrated ability to lead people in a positive manner.
- • Demonstrated ability to manage multiple and diverse projects concurrently.
- • Demonstrated ability to develop positive relationships and collaborations.
- • Strong analytical skills; a strategic thinker, planner, and implementer.
- • Ability to operate independently with minimal supervision.
- • Excellent written and oral communication skills and a command of the English and Chineselanguage.
- • Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
- • Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.