senior regulatory affairs specialist in Singapore

posted
contact
cyndi chin xin ling, randstad
job type
permanent

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
experience
5 years
reference number
91M0145656_1591153062
contact
cyndi chin xin ling, randstad
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job description

Senior Regulatory Affairs Specialist

Location: singapore

job description

about the company

A global pharmaceutical company developing drugs for the treatment of a range of disorders and diseases.

about the job

You will provide general regulatory advice especially in global drugs regulations. You will contribute to the development of regulatory strategies for global product distribution, identifying regional specific requirements for registration.

You will develop and maintain regulatory quality systems to support post-marketing authorization activities. You will also prepare documentation to support the marketing authorization / product registration application

You will also be involved in product development by providing clinical support in the design of clinical studies and gain studies approval. Pharmaceutical product registrations in major markets globally

Review and approve advertisement and promotional materials as well as to provide regulatory when required.

about the manager/team

This position reports to the Manager for Regulatory Affairs. Despite being an individual contributor, you will have the opportunity to interact intensively with various external stakeholders such as regulatory agencies, regulatory consultants, contract manufacturers and contract research organizations.

skills & experience required

You must be equipped with a bachelor’s degree in a scientific, technical or engineering discipline. You must have at least 5 years pharmaceutical industry experience with a minimum of 2 years in a Regulatory Affairs role, registering pharmaceutical products. Experience in cosmetic product safety, claiming, quality and registration will be preferred.

To apply online, please click on the appropriate link. Alternatively, please contact Cyndi Chin 6510 3656, quoting Ref No. 91M0145656.

EA: 94C3609 / R1215243

skills

Regulatory Affairs

qualification

Degree

educational requirements

Bachelor Degree