Regulatory Biotech Dossier Manager

1 semana atrás

São Paulo, São Paulo, Brasil Bayer Tempo inteiro

Regulatory Biotech Dossier Manager / CS / São Paulo - SP


At Bayer, we work hard to make this company a better place for our employees - and the world a better place for everyone.

"Health for all, hunger for none." That's our vision at Bayer.

Bayer is a global company with core competencies in the areas of life sciences, health care and agriculture. As an innovation company, we set trends in research-intensive areas. Bayer's products and services are designed to benefit people and improve their life quality.

GET TO KNOW OUR AREA:

We are part of the Regulatory Science team.

We ensure that the solutions we commercialize are safe for people and cause no undue harm to the environment.

We strive for regulatory approval of today's products and the technologies of tomorrow, being the enabler to business growth.


Our area is responsible to support Crop Science Brazil business developing and implementing regulatory strategies for innovations, life cycle management and regulatory defenses, in accordance with current legislation and internal policies and procedures.


MAIN PURPOSE:


The Regulatory Biotech Dossier Manager will be responsible for biotech dossier submissions in Brazil and will play a key role to develop and implement the cluster regulatory strategies for S&T innovations.

He/She must provide scientific and regulatory guidance to the Company for Biotechnology and Gene Editing areas in Brazil.

The incumbent has the responsibility to elaborate, develop and implement the cluster regulatory strategies for high quality dossier submissions to secure trait approvals that will bring innovations across all biotechnology portfolio and future pipeline in Brazil.

Responsible for strong coordination among global, regional and local multi-functional stakeholders, ensuring strategic communications through multiple channels available in R&D areas.

Accountable for leading initiatives to engage understanding of local regulations and ensure the awareness of potential uncertainties in the regulatory environment and explore winning strategies to improve efficiency and reduce approval timelines.


YOUR MISSION WILL BE TO:

  • 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 thirdparties 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 Bayer's 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 crossfunctional 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.

ARE YOU READY FOR THE POSITION?

Must-Have skills

  • Ph.
D. or M.Sc. Degree in Biology, Agronomy or a related Agricultural science, with In-depth knowledge in Molecular Biology, Biotechno

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