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25/07 Apurba Bhattacharya
Talent Acquisition at DuPont

Views:1939 Applications:28 Rec. Actions:Recruiter Actions:2

DuPont - Manager - BioTech & Regulatory Affairs (8-12 yrs)

Hyderabad Job Code: 358841

Biotech Affairs Manager

Work Location: Hyderabad

REPORTS TO: Country Manager

Direct Reports: 02

Indirect Reports: NIL

Brief Job Description:

The position is responsible for planning, initiating, and managing registration and regulatory affairs activities for timely approval of biotech (GMO) crop products in India. This includes understanding the regulatory processes and requirements at the national level, developing regulatory strategies for specific biotech crop products, preparing and managing high quality regulatory submissions for trialing and commercial approvals, and responding to complex technical questions from government reviewers against tight schedules.

- This position would also be responsible for conventional (non-Biotech products) registration and Freedom-to-Operate (FTO) activities such as PPV FR&A, NBA, and related policy matters.

- The position will establish and maintain professional contacts with regulatory authorities in India, lead discussions with regulatory bodies such as RCGM, GEAC and other relevant regulatory groups that may come into picture time-to-time, build academic and industry contacts, stay up-to-date with latest developments in science and agricultural biotechnologies, and promote pragmatic science-based legislation.

- The position will also lead technical discussions internally with the Regulatory Sciences and Operations groups to conduct biosafety studies to meet current and anticipated requirements, and ensuring all technical issues related to biotech product approvals are fully addressed.

- Conventional registration would need continued engagement with internal stakeholders, mainly Research, Agronomy and Business, and also with external stakeholders such as PPVFRA and NBA.

Job Responsibilities include, but not limited to, the following:

Analyze the biotech regulatory environment in India and develop strategies for commercial approval of current and future ag biotech products containing new technologies such as insect pest control, herbicide tolerance and future traits as single or stacked events :

- Ensure that regulatory provisions are met to enable freedom to operate for all uses of GM crops (e.g. import, food, animal feed, cultivation) and with good connectivity to other relevant legislation (e.g. variety registration)

- Execute the strategy for commercial approval seeking input from the Business and related function for successful completion.

Promote the development and adoption of science-based regulations for trialing, for food/feed (import) authorization and for commercial cultivation of biotech products :

- In-depth understanding of current and new agricultural biotechnologies (eg, corn and rice) and their consequent compliance with regulatory requirements.

- Take proactive steps internally and externally to influence and promote science-based regulations and requirements leveraging biosafety data from other regions.

Responsible for technical input to the Regulatory Science team in designing and analysing complex biosafety data packages for the registration of biotech products in India :

- Initiate planning and designing of critical studies (internal and external) to satisfy specific regulatory requirements for biotech product dossiers.

- Monitor progress of regulatory studies within set timelines, review data and reports from regulatory studies, and provide appropriate interpretation to support current and future evaluation by regulatory authorities.

- Ensure that research study reports prepared internally or by external collaborators are able to satisfy regulatory requirements.

Responsible for compiling and submissions of extensive technical regulatory dossiers on biotech products for commercial use in India (trials/import/food/feed/cultivation) :

- Understand technical requirements in current and pending biotech regulations for trials (BRL trials), import, animal feed, human food use and cultivation.

- Identify current and anticipate any changes in data requirements for the compilation of specific product dossiers and work to satisfy these requirements in a timely manner.

- Critical interpretation of technical data to compile and prepare trials and product dossiers for submission to the appropriate regulatory authorities.

- Track progress of submitted trials and product dossiers and prepare responses to requests for further information from regulatory authorities within tight deadlines minimizing any delay on timelines for approval.

Ensuring Hybrid protection, notification and FTO :

- Ensure that the business critical germplasm is protected under PPV&FRA.

- Understand the business priorities on the hybrid advancement; ensure the timely completion of the DUS data and applying for PVP registration for hybrids and parents.

- Maintain the continued engagement on technical and professional fronts with the PPVFRA and NBA authorities to position our priorities and drive through.

- Need to understand existing rules and regulations under the scope of NBA and other policies related to seeds movement and day-to-day business operations. Drive our opinion individually and through Industry platforms with the regulatory authorities.

- Give clear guidance to internal business team on Seeds policies.

Other responsibilities :

- Oversee the archiving of applicable registration records and information as per RIDM guidelines and policies.

- Provide technical support and regulatory advice to the India business unit. Identify key issues and apply scientific principles during development of technical guidelines by regulatory authorities at national and/or regional level.

- Represent Pioneer/DuPont on biotech regulatory committees for the development of harmonised industry positions on the safety assessment of GM crops.

- Keep abreast of latest scientific and regulatory activities, provide technical updates and seek functional guidance and direction from the Registration and Regulatory Affairs Manager for South Asia region.

Job Qualifications :

- MSc or PhD preferably in biological or agricultural sciences with 8- 10 years research and regulatory experience, or equivalent

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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