Biotech and Regulatory Affairs Manager
Job Description
REPORTS TO: Country Manager
BRIEF JOB DESCRIPTION:
JOB QUALIFICATIONS:
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 QUALIFICATIONS:
- MSc or PhD preferably in biological or agricultural sciences with 8- 10 years research and regulatory experience, or equivalent
DuPont Pioneer is the world leader in the plant biotechnology area including the discovery, development and delivery of elite crop genetics.
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