Acino Holding Dubai Jobs 2022 – Apply Online Regulatory Affairs Manager Vacancy in Dubai, UAE

Your Responsibilities will be :

Write and maintain all Chemistry Manufacturing Control (CMC) sections of the regulatory files for locally manufactured products within the assigned region.
Perform due diligence on Modules 2-5 of the local Regulatory files before new registration or acquisition.
Advise Business development and other functions on the quality of the Regulatory files before acquisition of molecules/products.
Write the CMC part of Modules 2, 3, 4 and 5 of the local Regulatory dossiers in CTD/eCTD format in English according to EU/local regulatory requirements, in cooperation with the local manufacturers.
Collect and compile necessary raw data, documents, and samples (active substance, impurities, finished product) to be included in the Regulatory file.
Update and maintain all CMC sections of the Regulatory files in validated systems (Footbridge).
Perform deep and accurate due diligence on the local Regulatory dossiers within the MEA region according to internal process/guidance and according to EU/local Region regulatory requirements. Discuss the due diligence outcome and report with all stakeholders and document according to internal guidance.
Handle variations to the dossier in accordance with the Change Control process in TrackWise system.
Prepare responses to requests by the Competent Authorities during the evaluation process, and timely handle deficiency letters within a specific time frame.
Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers in the region.
Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Clinical, Production area, Medical Affairs, Pharmacological and Business Development).
Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacological training.
Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacological/ Medical Affairs.
Manage one or more direct reports

Your Profile :-

Education in Pharmacy, natural Sciences, Chemist, Bio Chemist, Bio technologist, or relevant discipline.
Minimum 5 years professional experience in Regulatory Affairs in the pharmaceutical industry (Research and Development, Quality Assurance, Quality Control departments).
Good understanding of analytical methods for quality control of medicinal products, validation of analytical procedures and validation of technological process, procedures of bio equivalence / clinical trials/ bio waver.
Knowledge of the structure and the specifics of formation and functioning of the dossier for medicinal products in CTD/eCTD formats.
Experience in writing and compiling of Modules 2-3 of the Regulatory dossier in CTD/eCTD formats in English, in close collaboration with local manufacturers.
Experience in due diligence of the Regulatory dossier according to EU and local regulatory requirements.
Knowledge of current legislation and corporate requirements governing regulatory activities (registrations, renewals, variations).
Confident knowledge and power user of specialized regulatory programs and databases.
Ability to maintain a structured documentation and archiving system.
High organizational and communication skills.

How to Apply for Acino Holding Dubai Jobs?

You can follow these steps to apply for great Acino Holding Dubai, UAE Jobs opportunity of Regulatory Affairs Manager Job Position.

You need to visit first Acino Holding Dubai Jobs Portal (Direct Link Given in the below hyperlink).
Then You should select the Regulatory Affairs Manager Job Profile to Apply.
Now fill all the Acino Holding Dubai Jobs Job Application Details.
Now drop down the page and click on the submit button.
Now wait for few seconds, Your Acino Holding Dubai Jobs Filled application form will be your screen.
Take a print out for future use.