Vice President, Global Strategic Regulatory Operations (GRSO) - Princeton , New Jersey, United States, 08540
The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise. This role sets strategic direction and is accountable for delivering all global regulatory services for all BMS products.
- Strategic leadership of the units responsible for the design, authoring and writing of scientific documents that support regulatory submissions globally; the management and publishing of these documents and dossiers for compliant and high quality global submissions, labeling creation and labeling operational support globally.
- Ensure adequate procedures and policies are in place to support compliance with global regulatory standards for regulatory documents, submissions and other services (i.e. electronic submissions).
- Leadership of the central regulatory team that provides strategic oversight to the Mature Brands regulatory services provided by vendors.
- Accountable for the business capabilities (systems and process) that support these activities, including ERBM and other regulatory information management systems; and driving strategic outsourcing in the provision of these services, balancing cost, quality, risk and speed to patient.
- Responsible for oversight and development of Global Regulatory Team Leads for LCM assets. Provide strategic senior regulatory approval of the strategies, submissions plans, and HA interaction plans for these assets.
- Responsible for monitoring and assessing external trends to inform and educate stakeholders including macro trends in regulatory agencies globally, the healthcare environment, therapeutic area market and brand business drivers.
- MD, PhD, Pharm D or advanced scientific educational equivalent.
Extensive experience in Global Regulatory Sciences including the management of global regulatory operational services.
Extensive experience in team management at the department level; with proven ability to manage large change initiatives successfully.
- Proven track record in the delivery of successful regulatory strategies working with development teams and regulatory agencies globally.
- Broad intelligence of regulatory environment across key regions, anticipation of future trends and impact
- Excellent cross functional communications skills and a decisive yet collaborative leadership style to drive results while managing relationships.
- Strong influencing/persuasive skills with a demonstrated ability to influence different styles and individuals at different levels in organization.
- Exceptional collaboration and analytical skills to ensure that emerging trends are well assessed and vetted for potential business implications.
- Experience leading matrix organization in ambiguous environment with frequently changing priorities.
- Strong knowledge of Healthcare environment, including political, regulatory and healthcare reform concerns.
- Strong budget management skills.
- Strong program management skills and experience leading large teams with complex and matrixed initiatives.
- Strong leadership and engagement skills.
- Experience managing employees and matrix team in fast pace environment.
- Creates a sense of purpose or vision for self, department and leadership team.
- Translates broad strategies into specific objectives and action plans.
- Sets challenging, but achievable objectives.
- Generates alternatives and assesses benefits and risks.
- Allocates resources according to strategic priorities.
- Makes critical choices that support strategy and ultimately the end-customer.
- Aligns personal, team and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them.
- Creates a unified and seamless team.
- Provides direction to others that clarifies their expectations and role.
- Communicates opinions, facts and thoughts with clarity, transparency and honesty.
- Seeks multiple perspectives and listens openly to others' points of views.
- Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
- Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.
- Focuses organization on key priorities that impact our business.
- Adapts to and/or drives positive change.
- Removes barriers and eliminates non-value added work.
- Demonstrates resilience and perseverance.
- Continuously builds a high-performance diverse team of people to achieve objectives.
- Develops self and others to improve performance in current role and to prepare for future roles.
- Seeks and welcomes feedback and responds to coaching.
- Provides frequent feedback and coaching to others on ways to improve performance
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.