Mujtaba Kamal Email & Phone Number

Dubai, United Arab Emirates

Responsibilities: Ensure Compliance with global KPIs• Ensures OPU compliance to company SOPs/LSOPs and local regulatory obligations.• Ensures and supports in creation of regulatory intelligence report when needed• Monitor OPU RA system data timelines as per the relevant SOP• Observation and fulfillment of Regulatory KPIs and responsibilities as defined by GRA for the various processes (e.g. CRCs, PSURs/PBRERs, renewals, CCDSs, etc.)• Provide Corporate with timely… Show more Responsibilities: Ensure Compliance with global KPIs• Ensures OPU compliance to company SOPs/LSOPs and local regulatory obligations.• Ensures and supports in creation of regulatory intelligence report when needed• Monitor OPU RA system data timelines as per the relevant SOP• Observation and fulfillment of Regulatory KPIs and responsibilities as defined by GRA for the various processes (e.g. CRCs, PSURs/PBRERs, renewals, CCDSs, etc.)• Provide Corporate with timely regulatory intelligence information in particular on accelerated regulatory pathways.• Back up CAPA lead for the OPUs where there is no CAPA Lead. Ensure that all CAPA Lead proper training for each role is timely conducted.Support and guide the local OPUs RA activities• Ensures best practice sharing in META• Escalate risk issues to the GRA /META• Create and maintain META submission plan• Ensures regulatory plans and strategies for NDA are in place.• Support OPU in resolving product issues with LHA and responses to deficiency letters• Lead and support regional platforms (eg: TARA groups )• Acts as a central contact point for RA processes and systems• Follow up on timely submission of Renewal; generate annual renewal list and follow up on a quarterly base with the relevant LRA on their renewal preparation, submission and RA system data updates• Follow up on timely submission of PSUR; ensure that an annual PSUR submission plan is created in coordination with local PV and follow up on a monthly base with the relevant LRA on their PSUR submission and CPD3 updates• Follow up on the Implement of system improvement initiatives in coordination with the corporate relevant functions and escalate to META RA Head topics when needed.Leadership:• Ensure learnings and the on boarding of the new joiners’ in the RA team.• Ensuring the team is aligned with all corporate RA requirements and values. Show less

Duba, United Arab Emirateds

• Manage the zone or country medical team(s) creating an environment for professional growth of team members• Evaluate & define a portfolio approach for Medical value creation across Zones / Local teams, ensuring clear priorities are defined at a local level for all CHC Medical team members• Actively shape the regional or local business direction through input into the zone or local CHC Leadership Team• Promote scientific innovation opportunities across our portfolio through… Show more • Manage the zone or country medical team(s) creating an environment for professional growth of team members• Evaluate & define a portfolio approach for Medical value creation across Zones / Local teams, ensuring clear priorities are defined at a local level for all CHC Medical team members• Actively shape the regional or local business direction through input into the zone or local CHC Leadership Team• Promote scientific innovation opportunities across our portfolio through proactive cross-functional working of team members in contributing to global strategic medical brand plans or developing local product strategic medical brand plans that align with brand direction• Openly exchange with internal & external stakeholders to build on innovative concepts• Ensure appropriate representation & collaboration by local Medical teams within Extended Global Category Medical Teams• Drive delivery of medical commitments at a local level by clearly defining the desired outcome(s) from prioritized activities defined in medical strategies, and define operational milestones to deliver on these medical commitments• Key activities include – developing insights / anticipating trends, identified & executing on science inspired innovation opportunities (claim enhancement, product development, life cycle management, medical evaluation of BD opportunities, local switch opportunities), scientific endorsement & stakeholder management, risk mitigation.• Ensure CHC Medical governance is implemented and ensure company/industry standards are maintained at all times• Build a fast acting, collaborative & innovative CHC Medical Affairs culture• Promote a transversal 1-Medical culture at an affiliate level in accordance with efforts made by the CMO Office, through the local Country Medical Council Show less

United Arab Emirates

 Leading Boehringer Ingelheim CHC Medical/regulatory platform for META region develop the regional medical strategy for the CHC portfolio  Support strategy implementation in LOPUs Give input to Global Medical Affairs Strategy Create training materials and train LOPU CHC medical team and field force  Support non-trial activities to evaluate real life self-medication management provide medical input and the medical approval for the CHC promotional… Show more  Leading Boehringer Ingelheim CHC Medical/regulatory platform for META region develop the regional medical strategy for the CHC portfolio  Support strategy implementation in LOPUs Give input to Global Medical Affairs Strategy Create training materials and train LOPU CHC medical team and field force  Support non-trial activities to evaluate real life self-medication management provide medical input and the medical approval for the CHC promotional materials Adapt Global Medical Affairs and brand plan to Regional requirements Adapt brand planning process in the LOPU Monitor competitor’s literatures, publications and develop counteracting claims supported by clinical evidences.  Facilitate and consolidate feedback from LOPUs to Global and vice versa Plan and execute medical educational programs for HCP’s and business partners Supervise and review local NTA, IIS and PMS projects Identify the unmet medical needs for META region and explore the potential of MA  Identify and manage regional societies together with LOPUs Implement medico-marketing matrix approach and build the brand team interfaces with other departments within the organization Monitor BI METACHC regulatory activities progress and update the regional management team to ensure timely implementation of the business objectives. Handling medical information requests and frequently asked questions related to BI CHC products. Consolidate insights and share with Global HQ Show less

Singapore

 Create training material and train OPU Mas and FF  Support strategy implementation in OPUs Give input to Global Medical Affairs Strategy Adapt Global Medical Affairs and brand plan to regional requirements Adapt brand planning process in the OPU Support OPUs with plan implementation steps Facilitate and consolidate feedback from OPUs to Global and vice versa Provide medical education on BI products to internal and external parties Supervise and review… Show more  Create training material and train OPU Mas and FF  Support strategy implementation in OPUs Give input to Global Medical Affairs Strategy Adapt Global Medical Affairs and brand plan to regional requirements Adapt brand planning process in the OPU Support OPUs with plan implementation steps Facilitate and consolidate feedback from OPUs to Global and vice versa Provide medical education on BI products to internal and external parties Supervise and review local NTA, IIS and PMS projects Identify and manage regional societies and consumer health care organizations  Manage the medical materials in medico-marketing activities for CHC within Asia/MENA region  Assure timely follow-up on patient cases Consolidate insights and share with Global CHC medical affairs team Provide medical in-put during the regional labeling committee activities Show less

United Arab Emirates

•Responsibility for all regulatory strategies for CHC products and for all regulatory implementation activities in the MENA region.•Manage the BI regulatory affairs function regarding the execution of regulatory affairs activities to achieve timely registration of new products, maintain existing licenses and influence the regulatory environment through effective interfacing with regulatory bodies across the Area. •Support the Commercial objectives for new and existing… Show more •Responsibility for all regulatory strategies for CHC products and for all regulatory implementation activities in the MENA region.•Manage the BI regulatory affairs function regarding the execution of regulatory affairs activities to achieve timely registration of new products, maintain existing licenses and influence the regulatory environment through effective interfacing with regulatory bodies across the Area. •Support the Commercial objectives for new and existing products.•Responsible for providing ultimate implementation of regulatory activities aligned with BI strategy. •Accountable for maximizing business opportunities for all products. This involves evaluation, preparation & submission of regulatory documents that are complete & properly formatted as per the local regulations and requirements.•Ensure regulatory compliance in the region and adapt local procedures to corporate standards.•Keep up-to-date on changes on MOH regulations/policies. •Develop effective working relationship with Key External Experts & reviewers at MOH to facilitate and deliver a maximized regulatory outcome. •Accountable for the maintenance of regulatory compliance throughout the life cycle for BI portfolio of approved items. •Maintain product labels as per the registered information with coordination with pack Management.•Finalizing the critical variations' files and the complex regulatory cases for MENA countries.•Liaise with MOH to ensure prompt & efficient handling of product recalls or any other regulatory/QA related issues.•Responsible for risk management in the regulatory department. Minimise BI “risk” and ensure continuity of product supply by pro-actively managing compliance issues.•Oversee the technical change procedure thereby ensuring that country product licences are in compliance with factory procedures.•Ensure that adverse events are properly reported to health authorities, and when required are adequately addressed. Show less

United Arab Emirates

Compilation of assigned product dossiers, timely submissions and regular follow-up to seek faster registrations of new products and product variations in the Middle East and North Africa region.Assist in establishing good and effective liaison with regulatory authorities and Boehringer agents in the region.Responsible for assigned Product maintenance activities including registration renewals, packaging components updates and patients’ information leaflet update. Ensure regulatory… Show more Compilation of assigned product dossiers, timely submissions and regular follow-up to seek faster registrations of new products and product variations in the Middle East and North Africa region.Assist in establishing good and effective liaison with regulatory authorities and Boehringer agents in the region.Responsible for assigned Product maintenance activities including registration renewals, packaging components updates and patients’ information leaflet update. Ensure regulatory compliance in the region and adapt local procedures to corporate standards.Asset in Arabic translation and check of accuracy in the product package inserts.Respond to legal authorities’ queries and requirements related to the assigned products.Support other departments within the company in regulatory related issues.Handling the regulatory step for work items received through the AMT and RSPP system.Updating the regulatory archive with new circulars and regulations released by the health authorities in Middle East and North Africa countries. Show less

Complete management of the warehouse which includes inventory control, stock control, stock Receiving and Dispatching.Preparing all Warehouse reports Including Staff management reports.Preparing Ministry of health Import Permits for Boots Products.Preparing Boots Products registration dossiers. Responsible for registration of Boots Vitamins & Boots Pharmaceutical products with Ministry of health.Responsible for all regulatory affairs issues related to M.O.H., Department… Show more Complete management of the warehouse which includes inventory control, stock control, stock Receiving and Dispatching.Preparing all Warehouse reports Including Staff management reports.Preparing Ministry of health Import Permits for Boots Products.Preparing Boots Products registration dossiers. Responsible for registration of Boots Vitamins & Boots Pharmaceutical products with Ministry of health.Responsible for all regulatory affairs issues related to M.O.H., Department of health (Dubai) and Abu Dhabi health Authority.Regulatory Affairs consultant for Boots Company in UAE. Following With Ministry of Health Regarding new store Opening procedures.Preparing Boots new stores For Preliminary and Final MOH Inspection.Dealing with governments Inspection team in different authorities (M.O.H. - Abu Dhabi Health Authorities- Department of health (Dubai)).Updating the company in regular basis with the changes in rules and regulations and forwarding any circulars related to the new changes to our concerned staff and managers. Solving Boots issues and obstacles with legal Health Authorities including press release approvals and advertising issues.Aide in interviewing and recruiting Boots pharmacists for UAE stores. Show less