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We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client.

Please see the following position summary:

- Client: Global manufacturer of Agrochemicals
- Position: Lead - Regulatory Affairs (Global / International)
- Position Level: Sr. Manager / AGM / DGM
- Products: Agrochemicals
- Markets: USA, Europe, Mexico, Brazil, Mexico, Columbia
- Job Location: New Delhi / Delhi
- Reporting to: Head - International + CMD

Purpose of Role: Develops and implements a regulatory strategy for the active ingredients (TC) and the formulations in overseas countries. Identification of key markets and suitable products in collaboration with International Business team. Interact with CROs for the generation of registration data, customers and consultants for dossier submissions.

Manage, control & monitor the registration activities and support regulatory, R&D;, QC and Manufacturing units to understand the regulatory requirements and technical aspects based on country specific regulations. Analyse the existing technical data for suitability of submission and suggest the Management for data generation from time to time based on requirements.

Role & responsibilities

- Manage the division in a pragmatic and cost-effective way for successful global registrations & renewals of technical and formulation products in all international markets.
- Review the dossier submissions by team and suggest the improvements needed.
- Led and manage regulatory team and provide them proper guidance and make sure assigned task in completed within defined time frame
- Planning, evaluation,



and monitoring of budget concerning the data generation or country registration related expenditures.
- Internal discussions within regulatory team to improve knowledge and implement suggested strategies.
- Actively monitor the developments on regulations across countries, analyze the impact on existing/ongoing product registrations or future projects.
- Collaborate with cross functional divisions and extend support in finding suitable products and for development of new products in various markets.
- Coordinate with CROs for data generation, budgeting and follow up for timely completion of Projects.
- Act as a Sponsor representative & study monitor for Toxicological studies (including mammalian toxicity, Geno toxicity and Eco toxicity) for submission to global regulators.
- Determine the technical equivalence of active substances and comparability of impurities.
- Risk assessment of Agrochemical active substances, intermediates, raw materials, impurities etc.,
- Act as a lead in coordinating with registration team members, R&D;, Formulation Development, and QC to ensure completeness of data for dossier submissions within the timelines.
- Determine technical equivalence of active substances and comparability of impurities for submission in overseas countries.
- Prepare (Q)SAR prediction reports for submission to various global regulatory authorities.
- Make risk assessment of Agrochemical active substances, intermediates, raw materials, impurities etc., from time to time.
- Conduct research on new regulations and their potential impact on companies existing or future products.
- Represent and participate actively on behalf of companys in Associations or Working Groups that are recommended by Management from time to time.
- Interact with Marketing team and customers for identifying suitable products.
- Act as a focal point to address industrial toxicology/risk assessment issues, demonstrate and defend the safety of Company's products and processes on global platform.
- Involve in development and training of the registration team members.
- Review the registration requirements & gap analysis provided by the team and prepare the budget.




- Acts as a Study Monitor for Toxicological studies (including mammalian toxicity, Genotoxicity and Ecotoxicity) according to international guidelines like OECD / OCSPP / EC/ICH

Preferred candidate profile

- M.Sc. / M.Tech. / M.Pharm / Ph.D. in Chemistry, Agricultural Sciences, Toxicology, Environmental Sciences, Life Sciences, or a related discipline.
- 15 to 20 years of relevant experience exclusively in the Agrochemical / Crop Protection industry, with substantial exposure to global regulatory affairs.
- Proven expertise in registration of crop protection chemicals / agrochemical products across international markets and management of end-to-end regulatory submissions.
- Strong preference for candidates with an educational background directly relevant to Agrochemicals / Crop Protection and International Regulatory Affairs.
- Hands-on experience with regulatory requirements, submission strategies, dossiers and registration processes across multiple international markets.
- Ability to develop and execute product registration and regulatory strategies aligned with business objectives and target-market requirements.
- Ability to review scientific, technical and regulatory data and assess data adequacy, compliance and suitability for regulatory submission.
- Strong capability to address regulatory authority queries, deficiencies and data requirements and coordinate appropriate responses with internal and external stakeholders.
- Proven experience in managing multiple regulatory projects, timelines, priorities, cross-functional teams and external consultants
- Robust technical knowledge in at least one core area such as Chemistry, Toxicology, Agriculture, Environmental Science or related regulatory sciences.
- Experience in regulatory project budgeting, cost planning and monitoring for international registration programs.
- Ability to work closely with R&D;, Chemistry, Toxicology, Biology, Product Development, Legal, Commercial and Business teams to drive registrations successfully.
- Must have a demonstrated and successful track record of registering agrochemical / crop protection products in international markets.
- Strong leadership, decision-making, stakeholder-management and communication skills suitable for a DGM-level Regulatory Affairs leadership position.

Recruiter's Contact Details:

Dharmesh Sikligar

BEST-FIT Recruitment Riders

G-7, Amrit Complex,

Opp: Mahavir Jain Vidhyalaya & Jain Derasar,

R.V. Desai Road, Near Goyagate Circle,

Vadodara-390001, Gujarat, India

Mobile: 09558802906

Website: www.bestfitrecruitment.co.in

📌 DGM Regulatory Affairs (Agrochemicals - USA, EU, LATAM & ROW), Delhi
🏢 Best Fit Recruitment Rider
📍 Delhi