RegulatoryAffairsManager-SaudiArabia Jobs in Jeddah - 2863619

Job Description

Job Purpose

The RA Manager will coordinate different regulatory activities (products submissions, renewals and updates) through coordination between plants and agents and continuous communication with all parties involved (incl official authorities)
The incumbent will ensure timely approvals; ensure ethical conduct and compliance with applicable national and international laws, codes and regulations, as well as Pharmacovigilance

Major Accountabilities

1 To ensure fast registration, reimbursement of Alcon products, and maintain existing files
2 Permanent coordination between RA teams in Alcon and distributors as well as health authorities
3 To develop and maintain a product database of all Alcon products regulatory status in KSA and ongoing registration,
defining the priority of each project (product - market) based on corporate strategy and regional specificities
4 To implement deploy the regional drug safety and pharmacovigilance policies, in line with local and International
regulations, corporate guidelines and the regional policy defined by Alcon policies
5 To establish and maintain good relationships with MOH, Regulatory authorities and pharma associations
6 Ensuring optimum visibility and priority to Alcon products registration
7 Control time lines (submissions - approvals- introductions) to cope with regional plans & strategies as well as production
plans & capacity through proactive communications with all relevant parties including RA, Packaging and SCM