Sr. Specialist _Regulatory Affairs & Pharmacovigilance person
Oman Pharmaceutical Product LLC. Company (Zynova)
مجموع سنوات الخبرة :11 years, 11 أشهر
• Overall responsible for regional and global regulatory affairs. Which include Product registration, Re-Registration, Variations, labeling, Product launches
Life cycle management and Pharmacovigilance updates in CTD, eCTD format for UAE, Saudi Arabia, Bahrain, Qatar, Kuwait, OMAN, other MENA countries, and ROW countries submission via eCTD/ Paper.
• Expert in Publishing submissions i.e. eCTD and Lorenz
validation
• Prepared dossier for Product registration, Re-
Registration, Variations, etc.
• Prepare and execute Regulatory strategies for aggressive registration plans for products registration, products launch and life cycle management in accordance with the regulatory objectives of the regional business.
• Liaises and Negotiate with the local health authorities and local distributors in regards to all regulatory affairs related issues (Technical documents, registration materials required by the MOH (products sample, chemical or HPLC columns, Working/reference Std. etc.)
• Prepare and maintain project plans for submissions and timelines of approvals.
• Develop effective relationships with local Ministry of health, local commercial organization, distributors and local distributors.
• Provide regulatory guidance and advice on regulatory
environments
• Coordination with plant for technical requirements for compilation of dossiers
• Review of technical documents for regulatory adequacy received from other departments prior to submission with Health Authorities.
• Preparation/ Revision the Patient Information Leaflet, SPC including artwork.
• Authorized Qualified Pharmacovigilance person, MOH, UAE.
• PV responsibility across the region including SAE Submission, PSUR planning & submission on time, audit preparation, SOP & labeling updates.
• Preparation and submission of dossiers to be submitted to the Health Authority (HA), along with the other administrative aspects (e.g. maintaining files, trackers, coordinating with the monitoring team etc.
• Responsible to plan, initiate, co-ordinate and monitor regulatory schedule leading to timely submissions and approvals.
• Preparation/ Revision the artworks (Patient Information Leaflet & SPC).
• Market Intelligence, Liaison with local health authority & networking activities
• Acting acts as a link between Company and the local regulatory authority. (Point of contact for local regulatory authority
• Project updates to the Team on monthly basis.
• Pharmacovigilance (PV) responsibility across the region including SAE dossier preparation & Submission, PSUR submission on time, audit preparation
Dossier review for Registration.
Review receipt( Application) to issue “NOC” for Form -29
Review receipt (Application) to issue export License
Review receipt ( Application) to issue Import License and Form 28D,
Pharmacology ( Pharmacy Practice)