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Job Ref. ID:

50529

Job Title:

Senior Associate

Division:

REGULATORY AFFAIRS

Country:

UNITED ARAB EMIRATES

Work Location:

UAE (RAK head office)

Job Type:

Senior Associate

Employment Type:

Full Time Employment (Un-limited Contract)

Job Description:

Purpose:

• Responsible for Variation & renewal file preparation and Gap analysis for registered products • Responsible to follow up requested documents from different departments to fulfill dossier compilation and queries raised by different health authorities

Key responsibilities & Accountability:

Key Responsibilities & Key Result Areas • Assist and prepare the variation /renewal files according to the guidelines as per country requirements. • Assist and prepare response dossier as per country requirements. • Review of internal document system & perform GAP analysis as per country specific requirements. • Request and follow up of documents required from other stake holder departments for regulatory file submissions. • Prepare the required certificates & arrange for the legalization as per the requirements of different countries. • Responsible to Archive renewal, variation and response files in designated folder for future references and easy retrieval of information • Provide support for additional tasks as per manager’s request. • Prepare and provide status in monthly report. Prepare required certificates and arrange for legalization as per country Core Competency • In terms of competency you are highly result oriented with strong sense of accountability & ownership. • Should accurately follow instructions with the ability to multitask and easily adapt in a fast-paced environment • Must be organized, motivated, focused and hardworking • Should be ready and willing to learn new things and implement in workplace, commit towards work & added tasks • Ability to prioritize, multi-task and work effectively under pressure to meet deadlines. • Good communication, interpersonal and collaboration skills. • Must be able to work in a cross-functional environment interacting with other internal and external departments

Qualifications:

- Education

• 4 years Bachelor Degree in Pharmacy / any equivalent field.

- Experience:

• At least 2-4 years’ experience in similar organization in pharma / Health care / Medical Industry.

- Training:

Key Competencies:

• Good in communicative English (communicating, writing and speaking) is mandatory & Arabic as advantage. • Excellent in MS Office (MS Excel and MS Word, etc.).

Technical Competencies: