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Professional Diploma in Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs Training in Singapore | Regulatory Affairs Courses

Pharmaceutical Regulatory Affairs Training in Singapore | Regulatory Affairs Courses

Regulatory affairs (RA) is a crucial profession within the regulated industrial sectors, such as pharmaceuticals, clinical research etc. Regulatory affairs department plays a vital role in the pharmaceutical industry because it is mandatory to fulfil all regulations issued by the applicable regulatory bodies like US FDA, MHRA, TGA, DCGI, HSA Singapore etc. Different countries have different regulations but the overall objective is the same, which is to provide better healthcare to their citizens and to make sure that only safe and effective medicines make their way to the market. Regulatory Affairs department is engaged in providing guidance about the development of new medicinal products from early stages, by establishing regulatory pathways and by preparing and submitting the appropriate regulatory dossiers to regulatory bodies. Regulatory Affairs is actively engaged in each and every stage of the development of a new treatments and in the post-marketing activities with authorized medicinal products.

Regulatory affairs professionals are engaged in product development from the early stage. Regulatory limitations and specifications need to be addressed when preparing the development plan. Development objectives and key claims have to be examined and adapted to regulatory guidelines and regulations. Consultations with the proper regulatory agencies are to be made as well. Regulatory professionals make sure that the information and data to be communicated and discussed with the regulatory authorities are presented in the right way at the right time. Regulatory affairs professionals develop the regulatory approach, plan for agency meetings, prepare and compile the questions and briefing documents; attend the meetings and handle all communication with the regulatory authorities. Since the regulatory environment is regularly changing the regulatory department provides advice on necessary adaptations to development plans and target product profiles.

program curriculum

Program duration

Self Paced 4 - 6 months (Maximum duration 18 months)

All individuals participating in the program Professional Diploma in Pharmaceutical Regulatory Affairs (PDPRA) are required to invest about 15 hours every week in their online studies

Program Assessment

Participants are assessed via an ongoing evaluation approach by the faculty. There is no single final completion exam. Participants are assessed based on the following:

Completion of online Multiple Choice Question tests for every lesson studied and ongoing submission of project work for each module.

The minimum eligibility criteria for the Professional Diploma in Pharmaceutical Regulatory Affairs would include either of the following:

  • Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc

  • Any degree in Medicine such as MBBS, BDS, DDS, BPT, BAMS, BHMS,, BUMS etc

  • Any degree in Pharmacy / Pharmaceutical Sciences

  • Any degree in Chemistry / Biostatistics / Bioinformatics

  • Any degree in Nursing / Allied Health.

  • Students in their final year of graduation for the above courses may also apply.

  • If you do not possess the qualifications mentioned above you may still be eligible to apply based on any prior relevant work experience and upon recommendation of your line manager. Please contact our admission team / counsellor for more information.

Program Fee

JLI has been globally acknowledged for its determination to provide economical yet high quality training programs to aspirants. You may use our Online Program Fee Calculator below to determine the tuition fee applicable to you for the current academic year.

Should your country not be available in the calculator or should you not be able to figure out the tuition fee that applies to you for this online training program please send an email enquiry to or contact the online chat support available on this website.

To know more regarding the application procedure please click here.

Program Support

Each participant enrolled in PDPRA is in close contact with a mentor throughout the program. The mentor is an industry expert working in a senior leadership position. The mentor can be approached at any time via email or phone. Participants can also communicate with peers and faculty via their study accounts to discuss any topic or question.

Upon completion of the program students are provided placement guidance and support for career development via the “Student Success Team (SST)”. To know more about the SST, please click here.

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