Responsibilities:
R&D Personnel in this level are responsible for interpreting and implementing department strategy with regards to R&D issues and leading a number of R&D team(s). This would involve a full range of managerial responsibilities including setting policies and procedures and recommending improvements to operational processes and procedures.

Key Accountabilities:
Strategy:
•Participates in the development of the departmental strategy in line with the functional strategy to ensure vertical alignment and horizontal integration with other interfacing departmental strategies across Research and Development.
•Ensures that departmental strategies and related strategic plans are developed and implemented, which are aligned with the vision and mission of Research and Development
Policies, Processes & Procedures
•Participates in the development and recommends improvement on Research and Development department policies, and procedures, and manages the implementation to ensure all relevant procedural/legislative requirements are fulfilled
Budget:
•Oversees the consolidation and recommends the Research and Development department budget and monitors financial performance versus the budget so that the business is aware of anticipated costs/revenues, areas of unsatisfactory performance are identified and potential areas of cost reduction or performance improvement opportunities are capitalized upon.
Projects:
•Leads and guides project management teams in the planning, organizing, management and control of various projects in order to ensure that the project cycle is completed meeting agreed project parameters (cost budget, timelines, scope and quality), standards and objectives
Job description:
1. Develop and monitor the implementation of department policies, and procedures and ensure implementation of all relevant procedural/legislative requirements.
2. Contribute to the development of department strategy to ensure alignment with the vision.
3. Manage the effective achievement of department objectives by setting individual targets, developing and motivating staff in order to maximize subordinate’s performance.
Confidential
4. Manage the day-to-day operations of R&D department by facilitating related professional work processes in order to achieve high performance standards.
5. Directs research and development activities by participating in technical discussions to aid in resolving complex issues and achieve product development in a timely manner with considerations for scale up/tech-transfer feasibility
6. Provides guidance for laboratory studies based on the design of experiments to achieve formulation optimization and product stability confirmation.
7. Reviews and approves documents for specifications, technology transfer, assists for scale-up in order to provide input for initial technology transfer batches
8. Develop the R&D budget to ensure that the activities within the department are implemented and processed as per the assigned budget.
9. Provide expert advice and support to Hikma’ s business units in order to ensure the best use of own capability in the delivery of business objectives.
10. Approve final reports in related areas to be shared with management for updates and progress.
11. Comply with all relevant safety, quality, health and environmental procedures to ensure a healthy and safe work environment
12. Maintains knowledge with latest guidelines, regulations, patents etc. to assist R&D development activities.
13. Manages cross-functional team discussions with other functions (QC, QA, Regulatory Affairs) on various tasks related to new product development projects to provide needed technical expertise that supports product development and approval.
14. Communicates with cross-functional teams for the evaluation of products from idea creation, selection and allocation of new product opportunities.
15. Coordinates investigations to address aberrant results, determine root causes of issues and recommend action plans.
16. Provides technical guidance internally to assist the formulation, analytical and manufacturing teams on the R&D methodologies and issues.
17. Manages interactions with external CROs to ensure high quality and on-time execution
18. Represents R&D and Pharmaceutical Sciences on multidisciplinary project teams while working collaboratively to ensure project progression.
19. Leads the R&D section in evaluating and introducing new technologies to facilitate and enhance development capabilities that meet business goals.
People Management:
• Manages the effective achievement of Research and Development departmental objectives through setting individual targets, developing and motivating staff in order to maximize subordinate performance.
Continuous Improvement:
• Stimulates subordinates and contributes to the identification of opportunities for continuous improvement of systems, processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.
Reporting:
• Manages the preparation of timely and accurate reports to meet company and department requirements, policies and standards.
Safety, Quality & Environment:
• Ensures compliance to all relevant safety, quality and environmental management policies, procedures and controls across the department in order to guarantee employee safety, legislative compliance and a 3 Confidential responsible environmental attitude.

Minimum Qualifications:
• Master’s degree with 15yrs or more experience
• Ph.D degree with 12yrs or more experience
Minimum Experience:
• Minimum 12 years’ experience in US/EU filing regulatory market filings
• Should have experience in filing more than 25 ANDA/EU filing experience
• Experience in novel technology like complexation, hot melt extrusion, spray drying, oral thin film, semi solids would be added advantage