Gerente de Assuntos Regulatórios - Sao Paulo, Brasil - Lilly

Lilly

Empresa verificada

Sao Paulo, Brasil

há 2 semanas

Postado por:

Ana Silva

beBee Recruiter

Descrição

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.

Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Main responsibilities:

Supervise the Regulatory Affairs Department to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements.
Foster an environment of operational excellence through regulatory expertise and managing and developing direct reports and collaborating with crossfunctional teams to successfully achieve Affiliate regulatory objectives.
Facilitate and cultivate external relationships with the relevant Government bodies and industry associations.
Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment.
Support the development and implementation of the Regulatory Plan and Strategy in alignment with affiliate business plans as well as regulatory requirements.
Develop and maintain product labeling, ensuring that it complies with local regulatory requirements and implemented within the designated timelines.
Lead regulatory quality oversight of Third Parties.
Manage and support internal and external audits / assessments / selfinspections.
Maintain company's licenses, authorizations and GMP certificates.

Minimum Qualification Requirements:

At least seven years industry related experience in regulatory affairs (experience with synthetic and biologic products is preferable).
People management & leadership experience.
Ability to adapt to challenging situations.
Project management skills.
Strong analytical, problem solving and negotiation skills.
Advanced/Fluent written and spoken English.
Excellent planning and priority setting.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

WeAreLilly