Regulatory Affairs Specialist At Johnson & Johnson| pharmacists Vacancies
Title: Senior Regulatory Affairs associate
Job Description:
The JENA cluster comprises Egypt, Jordan ,Libya, Sudan, Ethiopia, and any new business within the geographical scope.
The role is ultimately accountable for the local Regulatory Affairs team activities in the JENA cluster including filing strategy and compliance.
Empower the organization to foster collaborative thinking to further drive regulatory innovation and catching the right opportunities to shape the regulatory environment across JENA, utilizing GRA best practices.
Be involved in all aspects of the application to take the product to market.
Submit products files to MOH either for new registration or renewal and ensure that filing & submission meet local requirements & company objectives.
Coordinate the preparation, review, submission and follow-up of regulatory files that are properly formatted and in compliance with local regulations.
Execute regulatory plans and manage timelines to achieve the stated goals.
Ensure that relevant local regulations are properly communicated to the different stakeholders internally & externally.
Respond to inquiries from the different HAs.
Communication & Negotiation with ministry of Health to overcome any obstacles that may affect the product availability.
Develop & maintain relationships with Health Authorities & other relevant organizations.
Maintain current knowledge of existing as well as emerging regulations, standards and guidance documents.
Provide regulatory support to all company functions upon request.
Comply with local laws & HCC guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).
Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J&J guidelines.
Contribute in the development of Egyptian regulatory decrees & guidelines by active participation in pharmaceutical industry & MOH meetings.
Qualification needed :
Bachelor’s Degree in pharmaceutical Science
At least 6 years of experience in Regulatory Affairs.
Comprehensive knowledge of regulatory requirements, MOH regulations & guidelines.
Experience in use of a selection of the following technologies: Information systems based on database technology orWeb/Internet technology, document management systems
Fluent in spoken and written English and Arabic
Ability to manage multiple assignments
Ability to work in matrix environment
Organizational skills
Good communication and presentation skills, both verbal and written
Results and Performance Driven
Analytical Thinking
Flexibility/Adaptability