Evaluating and consolidating the individual registration plans of Hikma Egypt business units into one comprehensive plan that serves Hikma regulatory strategy and strives to achieve short and long term growth and market share objectives, identifying major hurdles to product registration and designing proper strategies for resolving them, in addition to developing and maintaining strong and effective relationships with internal and external parties as required.
Strategic:
- Supervising the implementation of the Regulatory Affairs function plans, as well as ensuring their compliance with Hikma rules and policies.
- Developing Regulatory Affairs function’s work plan; assigning work activities, projects and programs, monitoring work flow, reviewing and evaluating work methods and procedures, and directing such activities to serve the Function’s goals and plans.
- Proposing plans and programs that boost the effectiveness of the Regulatory Affairs function.
- Ensuring that work activities are carried out achieving the pre-set performance goals, and suggesting any necessary actions.
Technical & Executive:
- Establishing and implementing set strategies to ensure continuous development and growth of registration team in terms of competencies and skills.
- Directing all company registrations towards fulfilling submission and approval plans while monitoring and rationalizing the related registration expenses
- Setting Hikma Regulatory Affairs rules and policies.
- Setting registration plans that respond to sales and marketing management needs taking into consideration new regulatory trends
- Ensuring that Hikma current systems and practices will result in smooth and timely Registration of new products and in prompt response to changes in regulations
- Establishing and running a system for evaluating new product dossiers for regulatory compliance and suitability while studying various options and optimize drug registration process
- Ensuring standards are in place for preparing and submitting pre-approval and post-approval registration dossiers for newly developed pharmaceutical products
- Fostering strong relationships with decision makers in drug administrations, governmental parties, Ministries Of Health and similar committees and organizations to offset major regulatory hurdles
- Taking actions to optimize the drug registration strategy, rules, standards, policies and practices through considering various factors which have direct impact on getting the approval to register new pharmaceutical products
- Keeping up with the increasing scope and complexity of regulations locally and abroad to guarantee reflection into Hikma rules and policies
- Identifying complications encountered during registration processes and take actions to resolve related issues in order to ensure a timely and smooth registration process
- Reviewing the status of Regulatory Affairs registrations, comparing the current situation to registration plans and take actions to achieve defined objectives
- Providing regulatory advice and support to Hikma functions including Business Development function, Quality function and Sales and Marketing function and R&D
- Lobbying on health authorities regarding new regulations serving Hikma’s own interest to attain Hikma registration objectives is performed.
- Recommending on the preparation of products registration database to include product list, product registration status and registration requirements
- Assisting in the preparation of Regulatory Affairs budget through providing required information regarding registration plans requirements.
Job Details
| Date Posted: |
2016-05-30 |
| Job Location: |
Egypt |
| Job Role: |
Other |
| Company Industry: |
Pharmaceutical |
| Joining Date: |
2016-07-03 |
Preferred Candidate
| Career Level: |
Management |
| Nationality: |
Egypt |
| Degree: |
Bachelor's degree |
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