Position : Regulatory Affairs Pharmacist Executive Company : Granulab (M) Sdn Bhd Contract : Full Time
Salary : RM2,900.0 - RM5,000.0 Per Month
Location : Shah Alam, Selangor Postcode : 40460
Posting Date : 19 Jan 2021 Closing Date : 28 Feb 2021
Academic Qualification : Language Requirement : No
Job Description
Job Responsibility
Ensure submission of product registrations is carried out in a timely manner in compliance with internal and external regulatory requirements.
Manage and respond to product regulatory questions from the National Pharmaceutical Regulatory Agency (NPRA) and Biro Pengawalan Farmaseutikal Kebangsaan (BPFK).
Liaise with local regulatory authorities and Regional Regulatory Affairs to deliver timely and commercially advantageous license approval.
Initiate and coordinate license amendment .
Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial value of the label.
Ensure maintenance of all registration files for reference.
Ensure compliance with local, regional and corporate regulatory SOP's and other processes.
Provide regulatory support on patent and trademark issues.
Provide support crisis management and product recall.
Monitor and report on regulatory projects and regulatory environment on a monthly basis.
Supports marketing in providing regulatory information and updates.
Job Requirements
2-3 years of experience as an associate regulatory affairs dealing with a wide variety of registration projects and issues.
Candidate with university degree or equivalent in Pharmacy or Science.
Fluent in English and Bahasa Malaysia both in spoken and written.
Possess working knowledge of Drug Control Authority (DCA), Good Clinical Practice (GCP) guidelines, international and local regulatory guidelines and codes.
Proficiency in Basic MS word, Power Point, Excel and familiarity with use of databases.
Demonstrated ability in analytical thinking, project management ability, problem solving, written and communication skills
Job Benifits
Medical Benefit
Group Personal Accident Insurance
24 days annual leave
Training
Annual Bonus
Job Application
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