Job title: Regulatory Affairs Manager – South Asia
Company: Bayer
Job description: At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Regulatory Affairs Manager – South Asia
Job Purpose:
- Registration of Pesticides Environment Science (ES) in APCA countries (India, SriLanka, Bangladesh, Nepal and Pakistan): Registration of pesticides (license to sell) with Regulatory Authorities is mandatory before it can be commercially launched in APAC Countries (India, SriLanka, Bangladesh, Nepal and Pakistan). Hence this position is responsible for handling the registration projects and activities.
- Evaluation of registrability of the new compounds and to play key role in defining the registration strategy (Timeline, data requirement, preparing action plan etc) as per the country regulation and preparation of dossier in a time bound manner.
- Planning, coordinating and managing of various registration activities, preparing risk mitigation strategies for timely registration approvals in India for ES Products.
- Support business expansion by seeking label extension approvals, Endorsements of additional packs, other approvals as well as maintaining the license to sale of ES and ES products defense activities.
- Responsible for registration and label extension activities for ES.
- Serve as the Regulatory interface in the Project Management for ES registration projects for defining registration strategies, time lines, preparation of risk mitigation plans as well as providing regulatory inputs to the stake holders to develop business strategy.
- Registration support (Preparation of dossier, to arrange the samples for Registration submission, trials and resolve registration queries, renewals of registrations, etc.) for ES products in order to obtain license to operate in other APAC 2 countries by providing strategic inputs for development and regulatory planning including Registration timelines with aim for bringing the products early to market.
- Coordinator for APAC countries for various ES Global Projects (RegPrime, ReProC, CHAMP Projects).
- Responsible for fulfilling the registration documents requirements from India to the other countries across the Globe in order to facilitate Regulatory Approvals of ES in respective countries to meet business objectives. Scope (global, regional or local): Local India
Key Tasks: Part A : Registration of Pesticides in India :
Extraction of data from Global system (DART, Veeva), its review / analysis for its suitability for registration as per Indian guidelines.
Key Tasks:
- Science based interpretation of data, Identification of gaps and regulatory risk and preparation of risk mitigation strategies.
- Interfacing with Regulatory Affairs-Region International team, GRM and expert groups in toxicology, e-fate, Formulation Technology, PCM for receiving bridging statements, position papers / data waiver statements and relevant certifications. Coordination and follow-up with R&D for Chemistry & Packaging data required for new product registration. Coordination with CROs for obtaining toxicology reports.
- Data compilation and preparation of registration dossier for submission to the Registration Authorities. Preparation of online dosser for uploading on CIB & RC website and also uploading of DDCT dossier for Global reference. Responsible for replying to the queries/ deficiencies raised by the Regulatory Authorities by coordinating for organizing scientifically sound justifications or generating additional data, if required.
- To fulfil data gaps if any, from time to time, and submit Sample Import Permit applications, endorsement applications for Small molecules as well as ES Projects to CIB&RC.
- Data compilation and preparation of registration dossier for label expansion on use for new business opportunities / expansion of ES.
- Participation in Project Team meeting of assigned projects and play active role in providing regulatory inputs and regulatory strategies while discussing various topics (e.g. Identification of segment, data generation planning, Packaging concept etc) involving cross functional team. Part B : Registration of Pesticides for ES projects in SriLanka, Bangladesh, Nepal and Pakistan (SOA countries):
- Data compilation and preparation of registration dossier for submission to the Registration Authorities of Bangladesh, Sri-Lanka, Nepal and Pakistan.
- Close Coordination with other SOA countries counterparts to follow up and ensure timely registration/approval of ES products in the countries and providing them all support regarding information sought by Registration Authority. Part C: Country coordinators for various Global Projects :
- As a country coordinator for India, responsible for organization of samples for ES products as required for Registration data generation and for submissions to CIL as part of registration process.
- As a country coordinator for ES products for SOA (India, SriLanka, Bangladesh, Nepal) countries, responsible for uploading/ updating RegPrime.
- Representing Registration activities for ES products in ReProC Team. Participation in the activities related to mismatch in chemical composition, jotting out action plan, coordination with R&D, Region International for project implementation.
- Responsible for Registration related ES Global Champ Project wherein decision has to be given, registration impact on SOA countries because of Champ case initiated globally. Coordination with R&D, Region International for champ cases.
Key Working Relation:
- Functional Reporting : Regulatory Affairs Lead ES, APAC B. Internal Partners/Customers:
- Close cooperation with Registration & Regulatory Affairs, Region, International GRM.
- Co-ordination and interface with R & D for Chemistry and Packaging data generation for various registration projects , deficiency reply and sample submission.
- Co-operation and close working with ES Innovation team to provide early Regulatory inputs on various projects for decision making process.
- With Marketing function (ES): Provide Regulatory inputs Key Working Relation: support in regard to New Projects, Label extension registrations etc.
- With Global Regulatory Managers (for discussion on various certifications and position papers and local data generation).
- With General Manager – Regulatory Science, APAC: For updates on scrutiny of dossier at the Registration cell and also to understand the updates /developments at Registration Office.
- Head – Regulatory Affairs , APAC: To discuss various registration project related strategies and timelines, discussion on decision making topics on etc.
- Close Co-operation and interface with Regulatory and Technical Development, Bangladesh for various projects to be registered in Bangladesh.
- Close co-operation with Sales Manager, Nepal for various projects to be registered in Nepal.
- Close co-operation with Team – Regulatory Science
- Close co-Operation with APAC Team, Singapore C. External Partners/Customers:
- Coordination with CROs (e.g Intox, Pune and IIBAT, Padappai) for toxicology data generation and obtaining the toxicology study reports as per Indian Registration guidelines.
- Close co-operation and interface with country consultant/distributor, SriLanka for various projects to be registered in SriLanka.
- Co-ordination with different consulates/ Embassy for legalization/notarization/ attestation of Regulatory certificates as per country requirement.
- Regulatory Experts, CIB&RC
Qualification & Competencies:
- Postgraduate in Agriculture / Science preferably Entomology
- 5-10 years of experience in Product registration in the Pesticides Industry.
- Experience in handling Registration projects with cross functional exposure.
Skills and Knowledge:
- Comprehensive Technical knowledge on the subject, Understanding of the Registration process, norms, regulation, data requirement.
- Technical skill / expertise in planning, designing registration strategy, preparation of quality Registration Dossiers for better acceptance by regulators.
- Good working knowledge and skills to operate Modern global tools like DART, DDCT, RegPrime Veera, etc through which the registration information/data is connected/ accessible globally.
Competencies:
- Plan and Align : To ensure Registration projects are on track and all timelines are met
- Manage complexity: To deal with complex Regulatory environment and resolve Regulatory Issues.
- Collaborate: To collaborate will all the stake holders for obtaining data, resolving queries and timely registrations.
- Strategic Mindset: To strategize and resolve Regulatory queries.
- Drive Results: Drive registration project through various milestones up to obtaining registration.
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Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location: India : Maharashtra : Thane
Division: Crop Science
Reference Code: 626202
Contact Us
+ 022-25311234
Expected salary:
Location: Thane, Maharashtra
Job date: Sun, 17 Jul 2022 05:02:05 GMT
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