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Sr Manager CP Regulatory

4 months ago

New Delhi, India Syngenta Crop Protection Full time
Job Description

ROLE PURPOSE

  • Liaisoning with regulatory authorities (CIB&RC, CIL, ICAR , FSSAI , INM etc) for all regulatory submissions and follow up . Important role in developing Regulatory strategy.
  • Focal point for toxicology. Develop tox dossier, reply tox queries and other tox related regulatory challenges / issues.
  • Key role in Crop Life Task Force viz., Toxicology TF , Biostimulant/ Biologicals  etc.
  • Accountable for quality dossier submission to regulatory authorities of India ,  to ensure quality data generation from 3rd party CROs , Govt Universities /ICAR Institutes etc  , 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

ACCOUNTABILITIES

  • To obtain registrations in time bound manner from CIB&RC.
  • 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 / Household/ Public Health  products in India.   
  • To coordinate and liaise with CROs via continuous follow-ups and obtain quality reports for timely registering crop protection products in India.
  • Liaison with INM  authorities for Bio-stimulant , Biofertilizers etc registrations
  • To develop scientifically sound reply to the query of regulators after dossier submission.
  • To liaise with Regional  / Global stake holders in Syngenta  for various inputs for dossier and while replying to queries of authorities.   
  • Coordination with ICAR for comments / Peer opinion before granting registration.
  • 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.

 

 


Qualifications

4.  KNOWLEDGE SKILLS & EXPERIENCE

Critical Knowledge:

  • Ph.D. / M.Sc. in Agri. Sciences or allied sciences
  • Good understanding of generating Tox, 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
  • Ability to lead a small team

Critical Experience:

  • In-depth working knowledge of crop protection products (herbicides, insecticides, fungicides, plant growth regulators, bio-pesticides, Biostimulants , House Hold and Public Health ( known as SPS in Syngenta)
  • Good track record of Advocacy with  Regulatory authorities in CIB&RC , FSSAI, ICAR , CIL , INM and scientists of government institutions (SAUs / ICAR)
  • Regulatory experience of 12 -15 years in Crop Protection products registrations

Critical Skills:

  • 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
  • Ability to Communicate effectively (verbal and written) in English

SYNGENTA CORE DIMENSIONS

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

Level:  Professional

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

  • Number of registrations obtained
  • Number of molecules defended
  • Good experience of  liaising with Indian regulatory authorities , Govt. officers
  • Proven track record in obtaining new molecule registration by curbing regulatory challenges
  • Rich knowledge / Regulatory sense of precedents of various approvals from CIB&RC
  • Proven  contribution in  developing Regulatory strategy and assessing registrability

WORKING CONDITIONS / PHYSICAL DEMANDS

PHYSICAL DEMANDS OF THE ESSENTIAL FUNCTIONS:

  • Physically fit to work and to stay focused under pressure

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

 



Additional Information

  • Once a year Full body check
  • Competitive insurance scheme
  • Employee assistance program – to take care of your and your loved ones mental health
  • Paid Vacation of 30days, 12 Paid Holidays, Maternity and Paternity Leave, compassionate leaves
  • Education assistance – for your career growth
  • People first culture translated into ‘Most Preferred place to work 2022-23 by Times group’

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.

To learn more visit: www.syngenta.com and www.good-growth-plan

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