2 – 3 YearsHyderabad / Secunderabad
Brief Business Summary of Regulatory Science:
The Regulatory Science group is a part of E. I. DuPont, India, located in the Hyderabad area. It is responsible for conducting efficacy and safety related studies of genetically modified (GM) crops to be commercialized in India by Pioneer Hi-Bred International, Inc. The group consists of multi-disciplinary teams, including scientists as well as quality assurance and compliance personnel from a broad range of technical fields, working together with regulatory and biotech affairs in India and globally. We are currently seeking candidates as employees to compile technical reports of regulatory studies.
Regulatory Science Study coordinator will be required to work with CROs and research institutes to execute and monitor biosafety studies as well as write, edit, reconcile and manage high quality technical reports of the regulatory studies. He/She will also be responsible for compiling scientific communications including literature review, abstracts, posters, slide sets and biosafety study reports for publication/ presentation or for submission to regulatory authorities and/or internal teams.
1. Develop, revise, and proofread technical content that meets the needs of the regulatory field trials, biosafety studies and other regulatory science related studies or projects. This may involve interaction and collaboration with various scientific functions at many different levels.
2. Coordinate with CROs, research institutes and internal stakeholders to execute and monitor the study and related shipments
3. Coordinate with registration to procure the required permits to conduct the biosafety studies
4. Understand the documentation procedure completely as specified in the SOP and adhere to the same. Prepares applications and reports as per regulatory guidelines.
5. Performs quality control (QC) checking / proof reading of the regulatory reports and documents to meet the standards for regulatory submissions.
6. Generates templates for study protocols and reports.
7. As per requirement, prepares literature review, abstracts, posters, and slide sets and biosafety study reports for publication/ presentation or for submission to regulatory authorities and/or internal teams
8. As per the requirement, manages multiple short- and long-term projects simultaneously in a fast-paced environment and meet milestones.
9. Ensures review/feedback on reports from stakeholders, incorporation of comments or edits and completion of reports as per the timelines.
10. Follows and tracks trial or study status for forthcoming writing projects.
Maintains records for all assigned projects including archiving.
Initiate process improvements and participate in departmental efforts to develop and update documentation standards, templates and procedure
Salary: Not Disclosed by Recruiter
Industry: Chemicals / PetroChemical / Plastic / Rubber
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Regulatory Affairs Manager
Role: Regulatory Affairs Manager
Regulatory ScienceStudy Coordinatordocumentation procedureregulatory studies
Knowledge, Skills, Competencies and Experience
M.Sc. in biotech or applied bioscience with 2-3 years of biotech industry experience.
MBA or project management experience in addition to MSc would be preferred
Excellent written and oral communication skills, capable to collaborate and team work.
Education:UG -Any Graduate – Any Specialization
PG – M.Sc – Any Specialization, MBA/PGDM – Any Specialization
Doctorate – Doctorate Not Required
DuPont India is a subsidiary of US-based $27 billion E. I. du Pont de Nemours and Company, a 204-year young science and technology company and one of the oldest industrial enterprises in the world. Founded in 1802 in Wilmington, Delaware, USA, DuPont delivers science-based solutions for markets that make a difference in people’s lives. Today we operate in more than 70 countries worldwide. DuPont association with India is since 1802, when the first shipment of raw materials for black powder for explosives was imported from India into the US. Today, DuPont India markets a wide range of products in varied market segments including agriculture, food and nutrition; health care; home and construction; electronics; safety and protection; and transportation and infrastructure, bringing to life its powerful philosophy of The miracles of science� to create a better world for all. The company has production facilities in India for DuPont Engineering Polymers (at Savli near Vadodara, and at Madurai), DuPont Crop Protection products (at Savli), DuPont Liquid Packaging Systems (at Savli), DuPont Refinish (at Savli) and Pioneer� seeds (at Medchal near Hyderabad). We employ about 700 people in the country (in DuPont and in our subsidiary companies) and provide indirect employment to another 2500. The research & development activities of DuPont in India include an R&D center that conducts field trials for crop protection products, and nationwide R&D centers for Pioneer� seed research towards development of hybrids relevant to different crops in India. The Solae Company, a DuPont joint venture, has a regional application development center in India and supports pioneering research studies in the area of protein technologies through its association with various academic and research institutions in the country.
Recruiter Name:Not Mentioned
Contact Company:E I DuPont India Private Limited