Regulatory Affairs Jr. Manager
Jeddah, Saudi Arabia
Job Description
Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.
Role Summary: Responsible to ensure Jamjoom Pharma product submissions are complying with the guidelines and meeting the timelines as per annual plan through healthy relationship and strong follow up with inter/intra departments and regulatory associates. Responsibilities:
Qualifications:
Role Summary: Responsible to ensure Jamjoom Pharma product submissions are complying with the guidelines and meeting the timelines as per annual plan through healthy relationship and strong follow up with inter/intra departments and regulatory associates. Responsibilities:
- To supervise the subordinates for work related functions.
- Assist supervisor in review and assessment of the regulatory impact of all the change proposals / requests (CRs)
- To prepare, review and establish standard operating procedures for the regulatory affairs department
- To establish procedures or systems for publishing document submissions either in hardcopy or electronic formats
- Ensure correct/accurate dossiers are being sent to regulatory authority
- Advise the team on strategy and timelines for projects and regulatory submissions in the GCC market(s) with updated regulatory information to compile data from relevant sources towards regulatory dossier preparation
- Ensure submission documents are reviewed and meeting the highest standards possible for the product registrations in GCC market(s).
- Evaluation of new product dossiers for regulatory compliance and suitability for registration in GCC market(s).
- Coordinate with, QA, QC, formulation, SC, marketing, and AMD to compile the necessary documents for regulatory dossier submissions for the new product registrations in GCC market(s).
- Maintain awareness of current regulatory directives and guidelines to ensure that company's products comply with the regulations.
- Conduct critical reviews of key technical documents (including protocols, data and reports, pre-existing regulatory dossiers and related documentation) aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents.
- Create, maintain, and update registration database and/or factsheets for all the assigned products.
- Ensure effective co-ordination and follow-up with RA associates in GCC market(s) to facilitate communication in matters relating to product registration, renewal, variation submissions and approvals.
- Review / approve technical documents with concerned departments including Artworks/labelling and product information
- Lead the team for preparation, review, and collation of primary responses to Health Authority queries on the submitted regulatory dossier(s) for timely submission and liaise with regulatory authorities through local affiliates.
- Perform review of renewals and post-approval variations considering full life-cycle management of assigned products / projects in the GCC market(s).
- Supervise and monitor the progress of team and lead for assigned projects in terms of regulatory.
- submissions and timelines in the Anglophone Africa and Francophone markets by providing on the job training, mentoring, and imparting guidance on regular basis
Qualifications:
- Saudi National is preferred.
- Minimum 5 years of experience in the relevant field.
- Expert regulatory and scientific knowledge for product registration, renewal of marketing authorizations and variations as per current regulations in Saudi Arabia, GCC and other countries.
- Bachelor of Pharmacy/Master of Pharmacy
- Excellent oral and written communication and presentation skills.
- Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
- Proficient computer skills including MS Office, RIS, eCTD, SAP.
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Job Detail
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Job IdJD1424275
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationJeddah, Saudi Arabia
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EducationNot mentioned