senior regulatory affairs specialist in singapore

posted
job type
permanent
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job details

posted
location
singapore
job category
life science
job type
permanent
working hours
Full-Time
experience
5 years
reference number
91M0128851_1545276593
phone
000
apply now

job description

about the company

A global biopharmaceutical company developing dermatological drugs for the treatment of a range of severe skin disorders and diseases.



about the job

You will provide general regulatory advice especially in global cosmetic 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.

Cosmetic product registrations in major markets, including EU, US, ASEAN, Australia and China.

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 Pharmaceutical 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. Being a registered pharmacist with the Singapore Pharmacy Council will be very advantageous.

You must have at least 5 years pharmaceutical/cosmetic industry experience with a minimum of 2 years in a Regulatory Affairs role, registering pharmaceutical or cosmetic 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 Johari Masod on 6510 3651, quoting Ref No. 91M0128851

EA: 94C3609 / R1109554








skills

no additional skills required

qualification

Regulatory Affairs, Pharmacy

educational requirements

Bachelor Degree