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Regulatory Affairs Manager

Business

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

BusinessScience

In Malaysia

In Malaysia this job is mostly about getting medicines, supplements, cosmetics and medical devices registered and kept compliant with NPRA and the Medical Device Authority, often for the wider ASEAN market. Employers are pharma manufacturers, distributors and medical-device firms, mainly in the Klang Valley; titles usually start at 'Regulatory Affairs Executive'.

How people get into it here
SPM → Foundation/Matriculation (science) → Bachelor's in Pharmacy, Pharmaceutical Science, Biomedical Science or Life Sciences → Regulatory Affairs Executive (NPRA/MDA product registration) → Manager after about 5–8 years

Sources:my.trabajo.org

What you'd do all day

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

  1. 1Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  2. 2Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  3. 3Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  4. 4Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  5. 5Provide responses to regulatory agencies regarding product information or issues.
  6. 6Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  7. 7Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  8. 8Manage activities such as audits, regulatory agency inspections, or product recalls.
  9. 9Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  10. 10Maintain current knowledge of relevant regulations, including proposed and final rules.
  11. 11Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  12. 12Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
  13. 13Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  14. 14Participate in the development or implementation of clinical trial protocols.
  15. 15Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  16. 16Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
  17. 17Establish regulatory priorities or budgets and allocate resources and workloads.
  18. 18Train staff in regulatory policies or procedures.
  19. 19Develop and maintain standard operating procedures or local working practices.
  20. 20Contribute to the development or implementation of business unit strategic and operating plans.
  21. 21Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
  22. 22Coordinate internal discoveries and depositions with legal department staff.
  23. 23Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  24. 24Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  25. 25Monitor regulatory affairs trends related to environmental issues.
  26. 26Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
  27. 27Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.

Also known as

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

  • RA VP
  • RA Manager
  • RA Director
  • CMC Director
  • RA QA Director
  • Global RA Manager
  • Global RA Director
  • Regulatory Manager
  • Compliance Director
  • Regulatory Director

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).
BusinessDraws directly on Administration and Management — a top knowledge area for this role (O*NET).
EconomicsDraws directly on Administration and Management — a top knowledge area for this role (O*NET).
BiologyDraws directly on Biology — 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 Language91%

    English

  • Law and Government79%

    History (Sejarah)

  • Administration and Management74%

    BusinessEconomics

  • Biology68%

    BiologyAdditional Science

  • Education and Training62%
  • Administrative61%

    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 discussionsEvery day
  • Contact with other peopleContact most of the time
  • Dealing with customers or the publicNot at all
  • Leading or coordinating othersHigh
  • Indoors, air-conditionedEvery day
  • Outdoors, in all weatherAlmost never
  • Noisy environmentAlmost never
  • Time spent sittingAlmost all the time

Where this job is heading

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

  • Develop and review regulatory strategies, development plans, and implementation plans for the preparation and submission of new 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.

19%

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.

Growing role in the US

US Bureau of Labor Statistics data, not Malaysian. Shown because it's the only forward-looking demand estimate we have for this job.

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

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 Managers

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