We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Regulatory Regional Lead, MENA and AFRICA
- Participate in Regional Management Team meetings to represent region.
- Input into business development plans to be implemented across the regions.
- Contribute to strategy for development of local support in the region.
- Oversee operational activities of local resources within the region.
- Oversee and, where necessary, approves regional input into client proposals.
- Escalate to Head of Regional Management and Procurement issues related to local consultants/partners and quality of services provided.
- Represent region internally (PharmaLex) and externally (clients).
- Oversee resources & capabilities of the region and highlight need for further capacities for the region in case of increased demand.
- Provide operational support to client regional team with respect to ongoing projects within the region.
- Participate in client meetings to provide Regulatory input on forecasting, planning and tracking of activities in the region.
- Oversight of local activities within countries in the region.
- Close tracking of submission and approval status.
- Providing status updates to client stakeholders, e.g. Supply Chain, Regional Regulatory organisation, Commercial etc.
- Support country resources if deficiency letters are received from Health Authorities.
- Overall responsibility and accountability of the assigned program
- Responsible for defining and oversight of dependent workstreams (interconnected projects) needed to reach the overall strategic goals of the program
- Responsible and accountable for overall budget management including planning, forecasting and monitoring of assigned program
- Daily program management throughout the program life cycle
- Responsible to produce accurate and timely reporting of program status to internal and external stakeholders
- Primary contact for the client about the program status (activities and performance management), issue escalation and general topics related to the program.
- Ensures effective client and/or internal stakeholder management in close collaboration with Key Account Manager if assigned.
- Defines and communicates agreed RACI and program governance
- Ensures program staffing/re-staffing and back up staff to manage program continuity
- Set-up Operational Program Team with clearly defined roles, assign responsibilities, accountabilities and work packages
- Managing and leading program team with diverse array of talents and responsibilities
- Defines and implements internal and external communication plans. Ensures adequate and transparent internal program team, cross-VDC and cross-country communication
- Creates and maintain the program documentation, including all plans, timelines and reports
- Defines and reports KPIs
- Ensures budget from work order is monitored and invoiced and informs client on potential risks to the budget or change orders needed
- Identifies and manage risks and takes mitigation measures. Develops a robust risk mitigation plan
- Integrates cross-Value Delivery Centers (VDC) experts, Consultants and Alliance partners into the program, if needed
- Ensures relevant PM standards, workflows and process are implemented
- Leads internal and external events and workshops
- Identify opportunities for continuous improvement
- Key driver to ensure renewal of programs, i.e. steer RfP and bid defense process; responsible to have appropriate delegation for all roles in such a process defined
- Successful completion of a Master’s Degree or equivalent in pharmacy or other natural sciences
- +15 years of experience and broad knowledge in the field of Regulatory Affairs of human and veterinary medicinal products. In-depth knowledge of regulatory requirements in the MENA and AFRICA region, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs
- Proven experience in managing cross-functional and cross-country projects, including basic economic knowledge and experience to efficiently and effectively steer the dedicated projects
- Experience in leading Managers
- Proficient leadership qualities to analyse problems and to develop possible solutions
- Capability to motivate employees
- Capability Capability to professionally represent the country/department and the company both externally and internally
- Capability to coordinate different projects to be executed in parallel
- Professional written and verbal communication skills
- English language fluency. French language fluency is a plus
- Resilience, willingness to work a flexible schedule and travel
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.