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Advanced PG Diploma in Regulatory Affairs &
Medical Writing

Medical Writing Training Singapore | Regulatory Affairs Courses Singapore | Online Regulatory Affairs

Medical Writing Training Singapore | Regulatory Affairs Courses Singapore | Online Regulatory Affairs

Regulatory Affairs is a crucial area within pharmaceutical and biomedical research companies. Regulatory affairs departments help companies fulfil the applicable statutory requirements and with ongoing compliance. Regulatory teams help submit various applications to the regulatory agencies such as applications for approval of new clinical trials, marketing approval of new drugs and medial devices among many others.

Regulatory affairs professionals maintain good working relationships with the regulatory agencies that they commonly work with such as the US FDA, EMA, HSA Singapore, Ministry of Health etc. They are expected to always stay abreast of the changing regulations across different markets. The support and right advise of regulatory teams is crucial for the efficient conduct of new clinical studies and for bringing new therapies to the market quicker.

The regulatory affairs teams rely on well written, error free documentation for submission to regulatory authorities. The documents need to be as per the formats prescribed by the regulatory agencies and must contain all the information asked for by the agency. This is where the role of medical writers comes in.

Medical writers are people who specialize in writing science related documents. In a pharmaceutical company they primarily specialize in writing regulatory documents such as study reports, informed consent forms, investigator brochures, trial protocols etc, as well as developing marketing related documents such as promotional material for the physicians and patients etc.

The regulatory affairs and medical writing program conducted by the James Lind Institute helps its participants understand both the regulatory as well as the medical writing concepts in a comprehensive manner.

program curriculum

Upon program completion interested students may be provided with paid freelance writing opportunities or unpaid internships to get started in their career and to help gain some industry experience.

Program duration

Self Paced 6 - 8 months (Maximum duration 24 months)

All individuals participating in the program Advanced Post Graduate Diploma in Regulatory Affairs & Medical Writing (APGDRA-MW) 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 Advanced Post-Graduate Diploma in Regulatory Affairs & Medical Writing (APGDRA-MW) 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 APGDRA-MW 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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