Executive Director Regulatory Affairs

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.

Responsibilities

Deputy Therapeutic Area Head

Support the Regulatory Affairs Therapeutic Area Head for IN&F in this strategic leadership position responsible for leading and developing the global regulatory strategies, overseeing health authority interactions and for providing oversight for the preparation, review and evaluation of submission documents to global health authorities including FDA, EMA and PMDA. Serve as the Therapeutic Area Head delegate with the following responsibilities:

Responsible for the recruitment, hiring, retention, and development of Regulatory Affairs staff.

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.

Oversee all activities pertaining to interactions with FDA, EMA, and other health authorities and communicates outcomes to Senior Management and relevant governance committees.

Provides leadership and guidance to senior executives on regulatory matters pertaining to the IN&F Therapeutic Area 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.

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 for the IN&F Regulatory Team.

Responsible for budget management for the IN&F Therapeutic Area.

Regulatory Affairs Team Leader

Will be a key member of the GRSP Extended Leadership Team to ensure the development, implementation and alignment of regulatory strategies across projects and the IN&F therapeutic area. Will be responsible for leading, managing, mentoring, and developing regulatory staff who work on US and/or global projects. Acts as regulatory representative on various company-wide projects and initiatives. Support due diligence and business development assessments. Working with regional regulatory staff as Global Regulatory Leaders and US Regional Regulatory Leaders on assigned development assets and marketed products:

Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products. Review/provide counsel on product development plans.

Assemble the global regulatory plans for identified projects/products.

Influences and imparts broad expertise regarding US and international regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.

Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects.

Serve as the primary interface with health authorities on assigned projects.

Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them.

Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources. Works with regional international staff for diverse health authority submissions.

Global Project Role

On an as needed basis, provide individual project support as a Global Regulatory Leader and/or US Regional Regulatory Leader on IN&F projects where additional regulatory resources are required.

Skills/Knowledge Required

Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in oncology or inflammatory disease drug development preferred. 12-15 years pharmaceutical industry experience, including 8-10 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired. Thorough knowledge of the drug research, development, and commercialization process. Demonstrated specific expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional. Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve critical/complex business problems.

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.

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, disability or protected veteran status.

Company info

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