Want to be a Regulatory Affairs and Quality Pharmacist in MNC?

regulatory affairs MNC

Originating from the UK, this is my second year working in industry here in HK. At present I work for a European MNC where the office in Hong Kong is the hub for the Asia Pacific Region.

My role in the company is diverse and there is a lot of variety in my work. Firstly, I look after the Regulatory Affairs of several countries in the APAC region. This involves many things such as applying for new product registrations, applying for changes in existing registrations, designing/editing product packaging and ultimately making sure all these activities comply with the authorities of the specific countries.

My second role is in Quality. This area is pretty wide and encompasses many things. To put it in an easier context; it involves making sure what comes in is great and what goes out is superb and to do all the necessary things in the middle of the process chain to ensure this is always the case.

Other areas that I take part include Medical Affairs and Pharmacovigilance. With Medical Affairs it is about answering queries from customers, users, researchers etc. To answer a query, sometimes a lot of reading is needed and much collaboration with experienced and specialized colleagues from around the world takes place. For Pharmacovigilance, reports of adverse effects around the APAC region; either of common nature or new suspected cases are reviewed and rapidly relayed to our headquarters.

From Monday to Friday I’m at work for 9am where I spend the first half of the morning going through my emails from Europe which were sent to me overnight; it’s rare to get quick or even instant replies from them due to the time difference. I then work my way through the daily tasks and by 6pm I make sure all my emails are sent and hopefully by next morning I get my next batch of replies.

Regulatory Affairs and Quality Pharmacist, European MNC

6 thoughts on “Want to be a Regulatory Affairs and Quality Pharmacist in MNC?

  1. It is nice for you to share your working responsibilities in a MNC. I am curious which countries you need to deal with apart from HK (Regulatory Affairs).

  2. Hi Marco, I hope I could help the author to answer your question, APAC regional affiliates of MNC in Hong Kong generally covers Macao, Philippines, Singapore, Malaysia, Indonesia, Korea, Thailand etc… sometimes it extends to Japan and Australia.

  3. Hi Franco, what personality do you think is required for being a Regulatory Affairs and Quality Associate?

  4. Hi there Louis, for the RA part I would say – well organised, detailed work, strong communication skill, good time management (and be able to read a lot of registration related documents). Hope this helps!

  5. Thx Franco, I am actually not pharmacy graduate, then what knowledge do I need to acquire if I want to get this job? Or what advice will u give to me?

  6. Hi Franco,
    With a similar question as Louis, I am curious how can a non-pharmacy graduate get into the Regulatory Affairs position? Is working as a clinical trial associate in CRO a wise choice or a possible stepping stone to allow people to work in Regulatory Affairs later?
    Thank you very much, cheers.

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