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Regulatory Affairs Specialist

Healthcare

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

PharmacyScience

What you'd do all day

The tasks that matter most in this job, most important first.

  1. 1Coordinate efforts associated with the preparation of regulatory documents or submissions.
  2. 2Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  3. 3Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  4. 4Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  5. 5Prepare or maintain technical files as necessary to obtain and sustain product approval.
  6. 6Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  7. 7Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  8. 8Coordinate recall or market withdrawal activities as necessary.
  9. 9Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  10. 10Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  11. 11Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  12. 12Identify relevant guidance documents, international standards, or consensus standards.
  13. 13Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  14. 14Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  15. 15Review clinical protocols to ensure collection of data needed for regulatory submissions.
  16. 16Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  17. 17Recommend changes to company procedures in response to changes in regulations or standards.
  18. 18Participate in internal or external audits.
  19. 19Compile and maintain regulatory documentation databases or systems.
  20. 20Write or update standard operating procedures, work instructions, or policies.
  21. 21Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  22. 22Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  23. 23Develop or track quality metrics.
  24. 24Develop or conduct employee regulatory training.
  25. 25Recommend adjudication of product complaints.
  26. 26Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  27. 27Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  28. 28Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  29. 29Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  30. 30Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

Also known as

What this job is called on JobStreet, LinkedIn and in job ads. Search these too.

  • RA Analyst
  • RA Associate
  • RA Consultant
  • RA Specialist
  • RA Strategist
  • RA Coordinator
  • Regulatory Analyst
  • Regulatory Engineer
  • Regulatory Scientist
  • Regulatory Consultant

How far is this from you?

Roughly how much preparation this job usually takes. In Malaysia your UPU route and the programme's syarat still decide entry, so treat this as a guide, not a gate.

  1. 1

    Entry straight after SPM

  2. 2

    SPM + sijil / short TVET course

  3. 3

    Diploma / TVET (sijil–diploma)

  4. Typical entry

    Degree (ijazah sarjana muda)

  5. 5

    Postgrad (sarjana / PhD) or professional route

Typical educationBachelor's degree

Subjects that matter here

The SPM subjects worth your effort for this career, with the reason for each.

EnglishDraws directly on English Language — a top knowledge area for this role (O*NET).
History (Sejarah)Draws directly on Law and Government — a top knowledge area for this role (O*NET).
BiologyDraws directly on Biology — a top knowledge area for this role (O*NET).
Additional ScienceDraws directly on Biology — a top knowledge area for this role (O*NET).
Computer Science / ICTDraws directly on Computers and Electronics — a top knowledge area for this role (O*NET).

What you'd need to know

The subject areas this job leans on most, and the SPM subjects that build them.

  • English Language90%

    English

  • Law and Government82%

    History (Sejarah)

  • Biology69%

    BiologyAdditional Science

  • Computers and Electronics68%

    Computer Science / ICTElectrical & Electronic Eng. Studies

  • Administration and Management67%

    BusinessEconomics

  • Administrative63%

    Business

Tools you'd use

Software and equipment that show up in this job, worth learning early.

Where to learn these, free

Scholarships & funding

What the work feels like

Day-to-day working conditions, so you can tell whether the job suits how you like to work.

  • Face-to-face discussionsAlmost never
  • Contact with other peopleNo contact
  • Dealing with customers or the publicNot at all
  • Leading or coordinating othersNot at all
  • Handling conflict situationsAlmost never
  • Indoors, air-conditionedAlmost never
  • Outdoors, in all weatherAlmost never
  • Noisy environmentAlmost never

Where this job is heading

Newer tasks O*NET has flagged for this occupation, a hint at how the role is changing.

  • Develop guidelines for nondiscriminatory employment practices, such as affirmative action plans and equal opportunity employment policies.
  • Train employees on equal opportunity laws, guidelines, or policies, such as discrimination, diversity, harassment, or affirmative action.
  • Use emerging technologies, such as drones, for remote or automated inspections.
  • Complete or review death certificates, including the assignment of cause and manner of death.
  • Observe and record the positions and conditions of bodies and related evidence at the scene, through documentation or photographs.
  • Develop regulatory strategies for products.

AI and demand for this job

A few real, dated data points — not a single score. AI making some tasks faster usually means a job changes, not that it disappears.

43%

Share of everyday tasks today's AI can already help with (2023)

This estimate is from 2023 — already out of date, since AI moves fast. Treat it as a rough, aging starting point, not the current picture.

Pay in Malaysia

We don't have a sourced Malaysian salary range for this job yet, and we'd rather show nothing than a number we can't stand behind.

Where to check:

  • JobStreet and Hiredly job ads for this title
  • DOSM Salaries & Wages Survey
  • SSPA scheme tables, if you're aiming for a government post
See pay for a related career: Compliance / Regulatory Officer

Check what you may qualify for

Enter your SPM grades and see which routes and programmes you may qualify for. An estimate to plan with, not an offer.

Check my eligibility Not sure yet? Take the quiz

How to get here

Post-SPM pathways with programmes in this career's fields. Tap one to see real programmes and entry requirements.

Matriculation

One or two years, heavily subsidised with allowance. Competitive, quota-based entry.

12–24 months

Asasi / Foundation

One-year runway into a specific university: public via UPU or private direct entry.

12 months

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About this information

This describes what the job involves. Pay, demand and entry routes differ in Malaysia, so check the Pathways and Programmes pages for local requirements.

O*NET occupation: Regulatory Affairs Specialists

Job responsibilities, knowledge areas and work context from O*NET 30.3, US Department of Labor, used under CC BY 4.0. onetcenter.org