Associate Director Regulatory Affairs Oncology

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The Associate Director will assume 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.

Responsibilities

Support the preparation of, and participate in / lead (as appropriate), key Healthcare Authority (HA) interactions.

Assure consistent positions on common issues are presented to global HAs. Review 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.

Qualifications:

Scientific background with a minimum of a Bachelor's degree (PhD, MD, PharmD, Masters, desired) and 4 years of relevant experience in Regulatory Affairs.

Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired.

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.

Other Qualifications

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

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.

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

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1518681_EN

Updated: 2020-05-25 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com