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REGULATORY AFFAIRS PHARMACIST
REPORTS TO : RA Manager
LOCATION : RAK. UAE
Job Responsibilities:
q Execution of work associated with Regulatory/Registration support for submission to regulatory agencies of different countries as per allocated zones
q Ensure that all appropriate work complies with current regulations, and is performed in accordance with standard operating procedures and other required quality and safety standards as per the company policies.
q Manage to meet targets and timelines set by management.
q Contribute at a high level to creation and design of innovative regulatory strategies aimed at bringing products to successful approval in the shortest possible time; lead or participate in discussions with senior RA staff to resolve the work related issues in order to complete the task.
q Review documents related to all submissions, and associated amendments and supplements; including study reports, clinical protocols and product labelling.
q Liaise with specialized individuals and groups (e.g., Labelling) within RA to meet submission needs.
q Collaborate with PDL, QA, QC, Tender, Marketing and accounts departments in order to gather the information related to fulfil the regulatory requirements for submissions.
q Interact with colleagues from Julphar to facilitate and integrate Julphar’s contribution to regulatory documentation.
q Maintain up-to-date knowledge of regional and national regulations, guidelines and advisory documents.
q Update regulatory guidance as per their zones with the help of Country Manager/Agents.
q Perform other related duties as required by management.
Job Requirements:
q Bachelor / Masters in pharmaceutical sciences, or in related field with 3-5 years experience in a pharmaceutical environment.
q Typically, at least 2-3 years of relevant experience in regulatory affairs in the pharmaceutical industry, preferably in dossier preparations.
q Committed to a strong team working environment.
q Strong strategic and problem solving capabilities, able to evaluate risks and understand the impact of regulatory activities on business outcomes.
q Well-developed interpersonal, negotiation and diplomacy skills; ability to interact effectively with regulatory agencies.
q Excellent written and oral communication skills.
q Able to work under high pressure and to strict timelines.
q General computer literacy and experience with Microsoft Office, Adobe suite, database and submissions software.
The candidate must poses good command in written & spoken English and computer knowledge. Salary will be according to the experience & qualification.
Please apply with your recent passport size photograph and copy of certificate.
All candidates meeting the above Criteria may apply online at:
http://julphar.com/Career.htm
or email their CV at : job@julphar.net
mentioning the Post applied for in the email subject.
Post Box - 997,
R.A.K, U.A.E.
Fax: 07-2462462
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