|Job Description & How to Apply Below|
|Pharma. API - Regulatory Affairs Officer|
Position Vacant / Plant Location:
The qualified RA candidate should be an API (Active Pharmaceutical Ingredient) industry oriented. He should be proactive with strong ability to apply regulations, communicative, team player, self motivated, confident, computer literate and has excellent command of regulatory documentations requirements concerning cGMP (ICH) and EU & FDA guidelines. He should have recognized cultural skills to blend in within multi-culture environments .
Plant location will be in Riyadh / Saudi Arabia, however the job may require travel to accomplish job related activities whenever necessary.
- Good knowledge & experience in applying the US FDA, 21CFR, EU EDQM (Directorate for Quality of Medicines & health care) and the ICH regulations & standards.
- Good knowledge & experience in preparation, review and submission of Drug Master File in CTD format to regulatory authorities.
- Query Reply to Regulatory Authorities.
- Annual Updating of DMFs, with cooperation of concerned departments.
- Experience in reviewing analytical and organic chemistry for DMF compilation
- Experience in reviewing technical organic chemistry.
- He should have sound review knowledge on chemistry and regulatory requirements.
- He should able to deal with different markets (national and International) and ability to reach targets as per the company requirement.
- He should have good QA and QC knowledge to identify the defects easily.
|Skills / Industry Qualifications Required:||Age: |
Between 25 - 35 years
Bachelor or Master Degree in Chemistry or Pharmacy from a reputable university / Institute.
Desired Work Experience:
Minimum 5 years in pharmaceutical industry (preferred in the API field) with dedicated Regulatory Affairs (RA) work experiences. He should be Responsible in compilation of DMF’s, preparation, review and submission Drug Master File to various Regulatory Authorities like USFDA, EDQM, TGA, MHRA and MHLW.
|Education Level Required:||College|
|Experience Required to qualify for consideration:||5 to 6 Years|
|Additional Information / Benefits|
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