Regulatory biotech dossier manager – São Paulo/SP

São Paulo
Efetivo (CLT)
Biólogo
Biotecnologista
Engenheiro Agrônomo

Atribuições e Responsabilidades

• Design strategies for biotech dossier elaboration and submission in Brazil, leading the scientific and regulatory discussions with local, regional and global functions;
• Accountable to build and implement Brazil regulatory guidance, strategies and best practices for new Traits development, lifecycle management projects in conjunction with Regional and Global strategies, ensuring competitive and timely approvals to meet short and long term business objectives. Guide the development of a solution in case of critical issues or delays;
• Work with relevant Bayer Crop Science functions to ensure necessary regulatory studies to secure the registration of new biotech products in Brazil and defense of our existing products and projects or third-parties products in a timely fashion;
• Oversee and support team members to collaborate with Regulatory Science and Biotech functions to facilitate dossier creation, mitigate regulatory and compliance risks with conditions of approvals;
• Responsible for obtaining and defending Trait portfolio registration activities, promoting portfolio integrated solutions;
• Support the Senior Manager to ensure an effective communication with Local, Regional and Global Regulatory Managers to access technical information for dossier preparation and alignment with global PMO to deliver timely submissions and obtain import authorizations in Brazil;
• Provide regulatory information with adequate interpretation and guidance to relevant function/teams;
• Represents Bayer CropScience with regulatory authorities, lndustry association and internal and external Biotech forums, building and foster strong Partnership and contributing to modernize and shape the Brazilian regulatory environment in conjunction with key stakeholders;
• Actively participate at the different meetings and other regional and global company cross-functional networks to connect business needs with an effective regulatory strategy for biotech dossier submission;
• Provide advice to businesses on regulatory trends, decisions, their possible impact and how to respond. Anticipating new regulatory legislation and guidelines that may impact on the Bayer portfolio (development /marketed products) and influencing this;
• Responsible for the Post Market monitoring (PMM) planning and its execution. Including the negotiations with the third party companies that conducts the yearly survey, in case it is needed;
• Contributing to scientific papers publication to support the constant need for modernization of the local regulations, leveraging the scientific data produced in house and with external collaboration.

Requisitos/Perfil Desejado

• Ph.D. or M.Sc. Degree in Biology, Agronomy or a related Agricultural science, with In-depth knowledge in Molecular Biology, Biotechnology, Bioinformatics or Gene Editing areas;
• Demonstrated experience operating in a highly regulated environment.
• Proven application of analytical skills in a regulatory environment.
• Good understanding of all regulatory relevant scientific subjects. Show ability to apply principles of precedents to new situations and anticipate how government personnel would analyze relevant factors.
• Strong communication, network building with Authorities stakeholder management skills.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills.
• Fluent English and Portuguese, we are a global team.