Regulatory Manager East Africa & DB Countries
Share
Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Role Purpose
- Provide regulatory expertise to the Kenya and other countries in East Africa & DB Countries
- Plan and execute regulatory activities for the EA & DB Countries. Achieve extend and maintain the license to sell (registrations) for Syngenta products
- Find innovative registration approaches within the legal regulatory frameworks in the BA
Key Accountabilities
- Provide regulatory expertise to the EA & DB BA (including fitness and suitability checks for new projects in the context of local reg. requirements); find innovative registration approaches within the legal regulatory frameworks.
- Manage all registration activities for EA & DB Countries: including preparation of registration submissions according to national requirements as per the regulators requirements; answering specific follow-up questions from authorities; covering regulatory aspects of the product label promotional pamphlets and posters creation process; keeping the Syngenta internal registration database up to date. Cover regulatory aspects of formulation and product site/source changes.
- Provide country annual plans and timelines for new registrations and re-registration activities on time and in-line with EASA BA strategy and priorities. Track periodically review and report registration progress against targets. Keep the BA and AME regulatory team informed on regulatory activities and emerging issues which require proactive management.
- Proactively monitor and regularly update both the BA and BU on Freedom to Operate threats (ai reviews changes in regulations) define FTO action plans lead and coordinate in-country related regulatory advocacy activities.
- Establish and run a network with local officials (regulatory authorities) and represent company interests; maintain close contact with local partners to grow and maintain expertise in national registration processes and legislations.
- Represent Syngenta in the local industry associations actively participate and regularly report on any topic relevant to the company.
- Ensure link between local trialists and Syngenta crop protection development team to make sure that efficacy trialing and reports meet local regulatory requirements (compliance) and the required quality for dossier submission
- Proactively manage or carry out product-related issues.
- Support BA Customer Service/Order Management on regulatory matters (shelf-life extensions country of origin issues review of inspection certificates etc.).
HSE Compliance & Ways of Working
- Champion and ensure adherence to Health Safety Environmental standards regulatory compliance and Syngentas ethical principles while fostering an inclusive culture of safety-first behavior.
- Demonstrate personal leadership in promoting The Syngenta Group Values maintaining the highest standards of business conduct and ensuring all activities comply with company policies procedures and applicable regulations.
Qualifications :
KNOWLEDGE EXPERIENCE & CAPABILITIES
Critical experience and knowledge
- A bachelors degree in science/agriculture or relevant technical qualification.
- Good knowledge of regulatory requirements and trends in East Africa & DB countries.
- Good knowledge of EU registration and general registration requirements.
- Understands development cycles for CP Experience
- Experience in regulatory affairs gained through 3 or more-year direct experiences in a regulatory role.
- Demonstrated strengths in communication self-organization and problem solving.
- Developed negotiation/influencing skills across different cultures
- Feel for the right moment to consult & update the manager on key decisions and issues.
- attention to detail and ability to complete and deliver tasks on time.
- Analytical and conceptual thinking with planning and implementation ability.
- Good communication in English and local language if needed
Core Competencies
- Customer Focused Builds up and maintains networks with relevant customers and stakeholders knows the customers needs and strives to provide them
- Innovative Track record of developing innovative growth options and challenge the status quo tries different and novel ways
- Trusted Gains confidence and trust of stakeholders and team
- Team Oriented Actively participates as a team member collaborates effectively across organisation & geographical boundaries and is able to bring out the best in people by a mix of challenges and motivation and seeks/shares best practice
- Results oriented Sets clear ambitious and achievable standards and goals and delivers on commitments and goals
Additional Information :
Location: Kenya depending on job need.
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
