Regulatory Manager EG
Share
Job Location:
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Role Purpose
The overall purpose of the regulatory manager is to support the Regulatory Lead in Egypt in:
- Secure the business and defend the interest of Syngenta.
- Design and implement all registration strategies for NPIs (CPs L&G and Fertilizers).
- Maintain the validity of the registration for the current portfolio.
- Lobbying with local authority for all regulatory aspects.
- Give support to the internal stakeholders.
- Represent the regulatory in front of the internal and external stakeholders.
Accountabilities
- Keep good relationship with all regulatory bodies and the authorities.
- Manage and implement all the official documentation from and to the regulatory bodies.
- Manage the registration of NPIs and their maintenance.
- Maintaining and strength the existing products.
- Manage to keep the Registration Certificates and Labels are valid for all products.
- Manage all regulatory matters relevant to technical and formulated samples.
- Manage all regulatory matters with APC CAPL Fertilizer committee and all other official entities.
- Manage all risks might impact the business on short and long terms.
- Manage all activities relevant to the Official Trial Program (OTP).
- Manage the data base and information in all regulatory systems by keeping it up to date.
- Lobbying with the officials and act as a Contact Person between the company and the regulatory bodies.
- Execute timely communication of key regulatory decisions while articulating their business implications.
- Oversee strategic planning and implementation of New Product Introductions (NPIs) Label Extensions (LEXs) and Re-evaluations for Egypt ensuring adherence to planned budget and execution timelines.
Critical success factors & key challenges
- Deliver of objectives whilst working across a complex range of internal and external interfaces.
- Successfully building communicating and implementing regulatory strategies.
- Achieving targeted regulatory goals on time.
- Develop new ideas fostering regulatory effectiveness.
Qualifications :
Knowledge experience & capabilities
Critical knowledge
- A degree in agricultural sciences plant protection/ pesticides is preferable.
- At least three-year experience in regulatory affairs and regulations.
- Technical knowledge of pesticides fertilizers and agricultural sciences.
Critical Experience
- Demonstrate strengths in communication self-organization and problem solving.
- Ability to work flexibly across a range of issues.
- Trials and technical background in testing and using of agrochemicals and fertilizers.
- Intimate knowledege of regulatory legislation and regulatory affairs network.
- Understanding the culture and behaviour of the people working with.
- Negotiation interpersonal analytical and organizing skills.
- Ability to Compromise.
- Managerial skills.
Critical technical professional and personal capabilities
- Ability to deal with different interactions (Superiors/ peers/ Collaborators) at national and international levels.
- Ability to plan coordinate and track multiple projects simultaneously.
- Time management encompassing registration deadlines.
- Understanding the teamwork.
- Working under stress.
- Attention to details and ability to complete and deliver tasks on time.
- English Arabic: Fluent (Spoken Written).
- Microsoft Office application and Internet surfing and browsing.
Critical leadership capabilities
- Potential and ambition to develop into broader and more senior Regulatory Manager role as experience develops.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
To help feed 10 billion people while reducing emissions and improve biodiversity. This is our mission as the global agriculture technology leader. With 59,000 employees in more than 100 countries and hundreds of thousands of agricultural partners worldwide, we are committed to transfo ... View more
