Regulatory Affairs Manager
Location: Shakopee, Minnesota, USA SUMMARY/PURPOSE:
This position has responsibility for Betaseed/KWS regulatory activities in North America.
The main emphasis of the position will be the submissions for biotechnology corn research activities in the USA and Canada.
Responsibilities include all phases of the process for the import, interstate movement and environmental release of regulated biotechnology crops in the U.S and Canada. It will also will be tightly involved in all steps to organize own deregulation submissions for cultivation and food/feed uses of new GM products. It includes all steps of data collection, dossier preparation, filing and contact to the respective authorities.
The position is tightly connected with the Regulatory Affairs Biotechnology group of KWS SAAT AG, reporting also to the Head Regulatory Affairs Biotechnology, technically.
ESSENTIAL JOB FUNCTIONS:
- Coordinate and manage the process for obtaining approvals for GM products.
- Carry out the preparation, including substantial independent writing of regulatory applications for submission to the responsible authorities in the U.S. and Canada.
- Evaluate and assess the safety of GMOs and genetic engineering projects.
- Perform the management of regulatory activities including requirements for annual reporting, complying with conditions of approval, and maintenance of registrations.
- Coordinate scientific studies as part of the application process.
- Build up a strong and reliable network of contacts with Regulators, Associations and Industry.
- Participate in industry association efforts related to agricultural biotechnology.
- Other duties and/or regulatory submissions as needed by the business.
- Work within an international team.
REQUIRED QUALIFICATIONS, SKILLS AND EXPERIENCE:
- Masters or PhD in a relevant biological field (e.g. molecular biology, plant biology, entomology, plant breeding, etc.).
- Experience with regulated agricultural biotechnology products, through prior position in industry, academia, or government institution.
- Knowledge of regulatory systems for products of agricultural biotechnology, in particular, the U.S. and Canadian regulatory system at state and federal levels.
- Familiarity with the Regulatory Science data requirements to support approvals for GM crops.
- Knowledge of a broad range of scientific disciplines including: plant molecular biology, general agricultural science; familiarity with plant breeding and agricultural production desired.
- Excellent communication skills, written and oral.
- Proven independent ability to prepare succinct, scientifically accurate, and clearly written technical and regulatory documents.
- Demonstrate successful organizational skills, time management skills and strong attention to details. Also discreet and confidential in handling assignments.
- Show proficiency with MS Office products.
- Ability to travel, local and international per business needs.
If you are interested in this position, please apply by sending a cover letter and resume to careers@betaseed.com, attention: RAMC51612.
Only qualified candidates will be considered.
More positions from: Betaseed, Inc. Posted from May 16, 2012 until June 16, 2012 SeedQuest reference number: 26942 |