Director, Regulatory Affairs - Bristol Myers Squibb - Braine-l'Alleud

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.

Celgene, a wholly owned subsidiary of Bristol Myers Squibb, is looking for an experienced Director of Regulatory Affairs who will take leadership responsibility for global regulatory strategy within a development team (DT).

Position Responsibilities

• Leadership responsibility for global regulatory strategy within a development team (DT).
• Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
• Support the preparation of, and participate in / lead (as appropriate), key Health Authority (HA) interactions. Assure consistent positions on common issues are presented to global HA. eview and approve content of responses to queries from HAs for respective regions/countries.
• Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans.
• Develop target labeling and co-lead the cross-functional labeling team.
• Ensure consistent positions are presented in responses to global health authority (HA) queries.
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
• In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
• Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.

Degree Requirements

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS

Experience Requirements

Significant experience in regulatory affairs

Key Competency Requirements

Required:

• Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired. Haematology drug development experience preferred.
• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
• Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
• Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
• Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
• Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
• Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
• Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
• Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
• Experience utilizing leadership techniques to drive a team through the stages of team development.
• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.

• Communicates opinions, facts and thoughts with clarity, transparency and honesty.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.

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.