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Regulatory Affairs Pharmacist Executive

Regulatory Affairs Pharmacist Executive
Selangor   Shah Alam
Full Time   Law / Legal
Granulab (M) Sdn Bhd

Post19 Jan2021
Expiry28 Feb2021

Job Information

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

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