Dear Jane,
pharma regulatory processes concerning product documentation are
· marketing authorisation applications,
· change control processes finally taking place between companies and health authorities.
· process validations to ensure that the company procedures are in line with the applicable regulations (inspections)
· corrective and preventive actions (recalls, changes to regulations).
The target is to ensure, only safe and effective products may be marketed. In case of marketed products, the aim is to ensure, only reproducible Products ares manufactured during their life-cycle, which meet the specifications described in the marketing authorisation.
The changes are initiated by the manufacturing facility, medical department, safety department, legal department mostly.
Here are the changes: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001782.jsp&mid=WC0b01ac0580b18c7b
in case you expect to be employed in
· an affiliate, you are going to be involved in a special change control process, as middleman between company HQs and Health Authority,
· corporate regulatory, you will be involved in the same change control process, as the one controlling/generating the process towards the affiliates,
· a manufacturing facility, you will be involved in the same change control process, as the one controlling/generating the process towards corporate regulatory,
· in all cases you will be a special project manager and/or you need to compile relevant documents.
· You may start here: https://legemiddelverket.no/english/regulatory-affairs
The job description will guide you about required skills and experience.
Regards
Peter
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Peter Miko M.D.
ArtPharm
Gyermely
Hungary
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Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview
Dear Everyone,
I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!
Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?
Any advice and experiences would be much appreciated.
Thank you for your time.
Jane
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Jane Awuh
Trondheim
Norway
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