Senior Regulatory Affairs Manager
- São Paulo, Brazil
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Speed to Patient
Manages products, milestones, requirements and timelines to deliver regulatory submission plans in line with Business / R&D goals,
Partners highly efficiently with the local cross functional team to fine-tune submission plans towards flawless execution of the regulatory strategy and successful launches against base/best case,
Liaises with local / regional / global internal and external stakeholders to deploy timely and high-quality regulatory filings,
Identifies opportunities, anticipates risks and enables effective contingency plans when required to meet the targets and find acceleration opportunities,
Ensures local labeling & promotion compliance to accurately reflect BMS position on the benefit-risk profile of the products in alignment with local approved label and key product messages,
Continuously monitors competitive landscape and provides valuable regulatory insight for business plans accordingly to remain leaders.
Provides regulatory support to execute external stakeholder engagement plans for BMS registered products,
Drives asset/non-asset HA interactions,
Performs thorough assessment of evolving rules and regulations whenever is required, creates awareness across the organization about regulatory evolving environment,
Represents the company in trade association, pharmaceutical order, universities, key regulatory opinion leaders towards shaping the regulatory environment,
Builds strong regulatory relationships with Health authorities, pharma industry and other key external stakeholders,
Contributes to the evolution of the regulatory policy.
Builds, monitors and assesses metrics and enables initiatives towards strengthen compliance conformance and foster continuous improvement,
Manages talent by establishing and communicating clear expectations, serving as role model, providing effective feedback and coaching, developing people and preparing effective succession plan,
Builds personal credibility and strong working relationships, capable to engage and/or lead high performance multi-functional teams,
Is visible and communicates with colleagues at all level.
Continuously energizes others.
Brand Team Mindset
Acts as a key partner by providing regulatory leadership, co-ordination and support for the brand strategies in the country,
Wears enterprise hat in contributing to business,
Promotes Business / R&D synergies within the country,
Effectively liaises with regional/global matrix organization,
Acts proactively as a strong "A" in the cross functional discussions, leading those referred to regulatory strategies,
Shares best practices in regulatory function across the organization.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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