Rukia Mosa

A regulatory Professional with remarkable track record in collaborative, cross-functional teamwork within high-pressure environments. Adept at project planning and managing multiple tasks at once. Dedicated to enhance regulatory process and meeting business objectives.

Aim to be associated with a recognized and progressive healthcare organization that gives me scope to upgrade my knowledge, skills in accordance with the latest trends and be part of the team that dynamically contribute to the growth of the organization.

• Provide Effective regulatory affairs support covering scope of countries in Middle East, Turkey, North Africa.
• Build a clear regulatory roadmap for company portfolio with clear submission/estimated approval timelines. Present monthly metrics and KPI updates to management, ensuring the expansion of the portfolio of the organization and support the business objectives.
• Comprehensive knowledge of Prescriptions, consumer and Medical device regulatory requirements and their submission process in the related authorities.
• Coordinates with Corporate, Regional Regulatory Affairs and the local management to address correctly the plans, strategies and align on the expectation.
• Manage and support several processes related to packaging materials, promotional materials and other cross functional tasks with Operations, marketing.
• Create sustainable professional network with local regulatory bodies and external partners and distributors. Maintain through adequate customer relationship management.
• Initiate and contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
• Managed the hiring, training & development of the regulatory team to achieve the objectives.
• Part of the distributor selections team and support in review of contracts and related documents.
• Lead Quality & PV Management Review and report reliable KPIs on time, Document Control & Records Management, Training and Quality Planning
• Manage post-market surveillance and vigilance activities as safety and quality reporting.
• Identify Quality Issues and establish corrective and preventative actions (CAPAs) to mitigate potential or actual non-compliance risks and ensure compliance to all applicable quality standards & regulatory requirements
• Conduct distributor and supplier management and qualification activities (selection, assessment, on-site audits and audit CAPA follow-ups. Ensure Technical quality agreements and Safety agreements are on place and up to date with all partners.
• Being part of the GDP audit planning and performing for third parties, involved in the preparation and joined as observer auditor for GDP/GMP audit for Local Manufacturer.
• Develop Quality Skills by having Quality Training plans implemented and achieved for all GxP involved teams. Also develop & deploy Quality awareness/training for all employees.
• Implement and promote global online documentation tools to facilitate the GxP and non GxP documents implementation and revision through the system.
• Set up the Quality Management system and ensure having complete and update QMS documents as Local standard procedures.
• Ensure GDP compliance by supporting local and global operations team to manage quality issues as management of Temp. Excursions, rework/relabeling, returns and if any recall occur. Set up a 3 years plan for Mock recall to ensure effectiveness of recall systems at distributor level.
• Ensure maintaining up to date employee records as JDs, training records and plan in coordination with HR team.
• Successfully took the Role of Health Care professional Compliance officer, and implemented the guidelines needed to be followed by the organization.
• Performed Training and education session to maintain the compliance spirit.
• Part of the review process for any activities related to HCP and provide the needed approvals to permit such activities.

MedDevReg,- 2nd PharmaReg AfriSummit - Sept 2022

7th GCC Regulatory Affairs Pharma Summit - March 2022

ISO 9001:2015 Quality Management Systems requirements & Exam -  Nov 2020

Pharmacovigilance Training course ; Dubai   - March 2019 

GSDP Audit Training ; Dubai - Nov 2018

HCP Compliance work shop by Nestle Skin Health; Zurich - May 2018

2nd ISOP ME Chapter Pharmacovigilance Training; Dubai - April 2018

SCCE’s   Basic Compliance and Ethics Academy/ Dubai -  January 2018

2nd Emirates International Conference on Combating Counterfeiting; Dubai   May 2017

Emotional   Intelligence 360 Workshop/ Dubai-  April 2017

Change   Management / Dubai - Sept 2015

1st Middle East conference on inter-professional Education; Doha - Dec 2015

 eCTD strategies and Tool ; Dubai - April 2015

4th 5th and 6th National Pharmacovigilance Conference; Dubai - June 2014, Sept. 2015 and  April 2017

Basic & Advanced workshop for the Qualified person for Pharmacovigilance; Dubai  May &  December 2015

10th Middle East Regulatory Conference (MERC); Muscat - September 2013 

International Beyond Quality Forum; Dubai - March 2013

Management Forum's Pharmaceutical Regulatory Affairs in the Middle East Seminar  October 2011.

Attending a training program in CTD format for the preparation of the registration dossiers as per the EMEA guidelines (March 2010)

Pharmacy profession training in Pharmacies and Hospitals in Dubai (January 2008 – June 2008)