Regulatory Affairs Specialist FCO

QUALIFICATION : B.Sc/M.Sc (Toxicology / Agri / Chem / Agri-Biotech) or similar.

 

KEY RESPONSIBILITIES :

Manage the data gathering and compilation of studies (toxicology, chemical, efficacy) necessary for the submission and support of registrations
Closely working with FCO authorities to get registrations in time
Regular follow up with regulatory authorities on submission of files
Ensure all dossiers are prepared and submitted as per specifications to registration authorities within specified timeline.
Competitive intelligence on regular basis on new products as per CFO minutes
Regulatory affairs representative on cross-functional project teams
Maintaining appropriate files and databases to document such activities
Collaborate and coordinate with J-makers/partners/suppliers and product development team
Manage projects to maintain product registrations including label revisions, CFO responses, registration reviews etc
Serve on cross functional projects to provide subject matter expertise support to the business.
Prepare and maintain labels ensuring compliance with regulatory authority
Provide necessary compliance reports as and when required by regulatory authority
Participate in a multidisciplinary technical team to develop regulatory strategies and solutions for a wide range of Crop Protection & Nutrition products
Responsible for regulatory monthly status reports/updates
Monitor, assess potential impact, and develop appropriate action plans for new or emerging regulations, initiatives, and regulatory changes
RTT applications and sample inventory management of new developmental products
Participate in external engagement activities through industry trade associations, work groups or other relevant initiatives, as assigned (from time to time)
Preferred Industry: Agri inputs (Agrochem / Fertilizers / Pesticides)

 

COMPETENCIES : Good verbal and written communication skills.
Skill in Excel, PPT and Microsoft word.