Regulatory Affairs Specialist Cmc, Meta

2 weeks ago

Mansoura, Egypt Acino Full time

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

This position is based in **Cairo, Egypt** and will report directly to the **Regulatory Affairs Manager, META**. The role will be responsible for writing and maintaining all Chemistry Manufacturing Control (CMC) sections of the regulatory files for locally manufactured products within META region, in addition to all relevant processes.

**Your Responsibilities will be**:

- 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, and finished product) to be included in the Regulatory file.
- Update and maintain all CMC sections of the Regulatory files in validated systems (Docubridge).
- Perform deep and accurate due diligence on the local Regulatory dossiers within the META 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 timeframe.
- 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, Pharmacovigilance and Business Development).
- Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
- Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

**Your Profile**:

- Bachelor degree in Pharmacy or a relevant discipline
- At least 3 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 bioequivalence/clinical trials/biowaver
- 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

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