Sr Mngr-Registration &Regulatory affairs

Role Title: Senior Manager -Registration & Regulatory affairs
Location: New Delhi

About Syngenta:
Syngenta is one of the world’s leading agriculture innovation company (Part of 23 Billion USD Syngenta Group) dedicated to improve global food security by enabling millions of farmers to make better use of available resources. Through world class science and innovative crop solutions, our 28,000 people in over 90 countries are working to transform how crops are grown. We are committed to rescuing land from degradation, enhancing biodiversity and revitalizing rural communities.
A diverse workforce and an inclusive workplace environment are enablers of our ambition to be the most collaborative and trusted team in agriculture. Our employees reflect the diversity of our customers, the markets where we operate and the communities which we serve. No matter what your position, you will have a vital role in safely feeding the world and taking care of our planet.

To learn more visit: www.syngenta.com and www.goodgrowthplan.com

Role purpose:

• Accountable for quality dossier submission to regulatory authorities of India , to ensure quality data generation on bio efficacy , residues etc from 3rd party CROs , Govt Universities /ICAR Institutes etc for CP and SPS products ,meeting registration guidelines , in order to achieve registrations in a time bound manner.
• Effective Product defence as FTO/LTO operations for product Life cycle management
• Additionally to support the dossier for Sri Lankan registrations
• Accountabilities:
• To have a clear understanding and sound knowledge of regulatory and registration guidelines as stipulated from authorities and keep on evolving ,for registering crop protection / SPS products in India and Sri Lanka.
• To develop trial protocols for regulatory data generation in coordination with product biology / Field trialing team, scrutinizing various reports for their quality, correctness and acceptability for regulatory submissions.
• To coordinate and liaise with field trial team, agricultural scientific fraternity of SAUs, ICAR, IARI and CROs with continuous follow-ups and obtain quality reports for timely registering crop protection products in India.
• To develop scientifically sound reply to the query of regulators on bio-efficacy/ residues/ chemistry / packaging on FNE/ FEX / LEX dossiers.
• To ensure , quality MRL proforma as per the stipulated guidelines from FSSAI , along with relevant supportive documents for establishing National Maximum Residue Limits (MRLs) by FSSAI , is submitted and also to submit high quality responses to queries raised by regulatory authorities / FSSAI on MRL issues.
• To liaise with APAC / Global stake holders in Syngenta for various inputs for dossier and while replying to queries of authorities.
• Regulatory data generation and dossier compilation for SPS ( House Hold/ Public Health) products.
• Responsible for Sri Lanka registrations / documentation, to support 3rd party distributor in SL.
• Coordination with ICAR for comments / Peer opinion before granting registration.
• Interface with IARI , AINP on residues project for sponsored residue studies
• National MRLs – interaction and follow up with Food Safety & Standards Authority of India (FSSAI, MoH&FW).
• Support in Crop Life Activities (via Member of Core group/ Task Force )
• To adhere with company’s business aspirations by achieving milestones and timelines in a cost effective, efficient and cooperative manner.
• To adhere with Syngenta’s policy of regulatory compliance and work with honesty, dedication and positive attitude.

KNOWLEDGE SKILLS & EXPERIENCE

Critical Knowledge:

• Ph.D. / M.Sc. in Agri. Sciences or allied sciences
• Good understanding of generating bio-efficacy , residue data , chemistry data generation of crop protection and House Hold / Public Health products
• Registration and regulatory requirements of India
• IT literacy

Critical Skills:

• Good scientific writing and ability to prepare compelling technical arguments
• Excellent verbal communication skills in English
• Excellent organizational and analytical skills
• Attention to detail and thoroughness, particularly under time pressure
• Proactive attitude and a strong motivation towards working in time bound manner
• Ability to use computers and to work disciplined with database management
• Ability to work in a multicultural, de-centralized and multifunctional team
• Ability/willingness to travel regionally and occasionally globally
• High attention to detail and consistency in performance
• Good planner but also a good stress manager. Basic understanding of project management and planning.
• Ambition to grow in the job and in the company

Critical Experience:

• In-depth working knowledge of crop protection products (herbicides, insecticides, fungicides, plant growth regulators, bio-pesticides, House Hold and Public Health ( known as SPS in Syngenta)
• Established network of contacts with scientists of government institutions (SAUs / ICAR)
• 10 -15 years Regulatory experience in Crop Protection products registrations (dealing with CIB&RC,ICAR,IARI,SAUs etc)

Syngenta Core Dimensions:

• Results Oriented
• Team Oriented
• Decisive
• Communicative and open
• Customer-Focused
• Innovative
• Disciplined

Other Behaviors Critical for the role:

• Willingness to work as per deadlines
• Flexibility and willingness to travel as required
• Strong stewardship outlook, as part of approach to gaining registrations
• A good interpersonal skill is a must

Critical Success Factors and Key Challenges:

• Excellent understanding of generating registration data as per registration requirements of crop protection / SPS products.
• Strengthening and establishing excellent rapport with scientific fraternity ,Regulatory authorities
• Maintaining technical and regulatory compliance

Working conditions while performing essential functions:

• Domestic and international travel possible with overnight stays.
• Person must be fully conversant with (and willing to learn) the existing regulatory environment, rules and regulations and the evolving regulatory environment

Note: Syngenta is an Equal Opportunity Employer and does not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

Follow us on: Twitter & LinkedIn:

• https://twitter.com/SyngentaAPAC
• https://www.linkedin.com/company/syngenta/