Position Summary
Responsible for the
regulatory affairs, submissions support for dMed and its clients, implementing
drug registration operation service support as per project needs, such as IND,
NDA, lifecycle submissions and healthy authority query response, as well as the
submissions-related activity. Maintain good relationship with regulatory
authorities for business support. Keep apprised of regulatory developments and
understanding key regulatory changes locally and globally. Contributing to dMed
internal regulatory intelligence development, documentation system and training
program, supporting business opportunities, etc.
Key Responsibilities
Ensure
required regulatory support for dMed and its clients, implement drug
registration strategy plan or operational service as per project and/or
customer’s needs
Establish and
maintain good relationship with regulatory authorities and industry
associations for business support and understand key regulatory changes
Contribute to dMed internal regulatory intelligence
development, documentation system and training program, consultation and
support to business opportunities, etc.
Education and Key Competency Requirements
Master degree in
a life or medical sciences or relevant scientific background.
Knowledge of ICH Guidelines, local
regulations and GXPs including, but not limited in regulatory requirements for
the conduct of clinical development programs.
Superb organization, communication skills (oral
and written in Chinese & English) and strong interpersonal skills to be
able to effectively interact with customers, key stakeholders, health
authorities, multidisciplinary groups as well as with vendors.
Good learning, analytical and issue
identification abilities, and attention to detail
Creative problem solver and keen ability to
address current and anticipated issues
Good teamwork spirit and positive working
attitude
Proficient computer skills
Able to travel per business
needs