Vice President, Head Hematology Global Regulatory
Vor 4 Tagen
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.
**Functional Area Description**:
- Develops and implements global regulatory strategies
- Manages interactions and relationships with health authorities
- Ensures high quality submission documents and executes regulatory activities needed to secure approval of new drugs or approvals for expanded indications
**Position Summary/Objective**:
- Leadership position responsible for leading and developing the global regulatory strategies and for providing oversight for the
- preparation, review and evaluation of submission documents to health authorities including FDA and EMA. Responsible for the recruitment, hiring, retention, and development of Regulatory Affairs staff.
**Position Responsibilities**:
- Formulates regulatory strategy in collaboration with the SVP, Global Regulatory Strategy & Policy and oversees implementation of activities needed to secure approval of new drugs or approvals for expanded indications across product portfolio
- Manages all activities pertaining to interactions with FDA, EMA, and other health authorities and ensures the outcome communication
- plans arein place for Senior Management and relevant governance committees
- Provides leadership and guidance to senior executives on
- regulatory matters pertaining to Hematology to improve the effectiveness of regulatory strategies in order to bring new products to regulatory submission and approval in the most expeditious manner
- Works in close partnership with internal/external key stakeholders to effectively manage project development timelines and expectations
- Directs due diligence activities related to regulatory affairs and directs activities associated with external alliances
- Serves as liaison with Regulatory Agency boards to ensure rapid and timely approval on new drugs and continue the approved status of marketed drugs
- Establishes the procedures and resources require to meet our legal and regulatory obligations
- Provides strategic leadership in business processes and cross-functional partnerships
- Leads, mentors, and guides development of talent, which includes succession and development planning, performance management, and recognition.
- Responsible for budget management for Hematology
- Ensuring GRS representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative of the TA by delegation).
- Providing GRS representation as appropriate to review and endorse key documents (target labelling, pivotal protocols/study design, statistics analytical plans, Risk Management Plans, Pediatric Plans, Comparability Plans, etc. as appropriate).
**Degree Requirements**:
MD, Ph.D, or Pharm.D. degree preferred
**Experience Requirements**:
10 years or more experience in regulatory affairs
**Key Competency Requirements**:
- Strong knowledge and experience with regulatory affairs and FDA regulations, with knowledge of other key regions including EU, Japan, and China
- Significant line management experience of multi disciplinary scientific, medical and technical staff, if possible, in a similar function
- Entrepreneurial - with a track record of taking intelligent risks, courage in decision-making, and willingness to be held accountable
- A flexible, positive, and creative thinker with the proven ability to develop and implement innovative programs and processes
- Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals
- Superior leadership, management, and organizational skills, and a reputation as an open, available and transparent communicator
- Ability to interact effectively across boundaries with other global functions using influencing and relationship building skills
- Strong command of the drug development process, pharma business, and strategic portfolio management
- Senior management experience coupled with strong interpersonal, oral, and written communication skills. Strong leadership in representing the position of Global Regulatory Strategy & Policy to Senor Management and relevant governance committees
Travel is required
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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