Job Description

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.

Summary/Scope: 

A multifaceted regulatory role.  The Regulatory Affairs Team Leader: 

• Will be a key member of the regulatory management team to ensure the development, implementation and alignment of regulatory strategy across projects and therapeutic areas as relevant.

• Will be responsible for leading, managing, mentoring, and developing regulatory staff who work on US and/or global projects.

• May represent the regulatory affairs function on Global Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels. 

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Core Responsibilities:

Management Role

• Accountable for resource planning. Identify & communicate changes in resource needs to regulatory management team

• Lead the development and maintenance of Regulatory Affairs practices and procedures

• Guide regulatory staff in the development and implementation of regulatory strategy, submission strategy, and lifecycle management to ensure alignment with project team objectives (US and/or global)

• Maintain knowledge of US competitive landscape, regulatory environment, regulations and guidances

• Assesses the impact of new health authority guidances and provides insight and recommendations in collaboration with the Regulatory Policy & Intelligence Group

• Review and/or approve key documents before major regulatory submissions (US and/or global)

• Maintain oversight of key interactions with FDA

• Communicate FDA feedback as appropriate to regulatory management team

• Act as a strategic partner in the governance committees within the company

• May participate in Business Development efforts

• May engage with FDA on US-related policy

• May participate in or lead cross-functional initiatives

• May participate in or lead industry initiatives (eg, workshops, symposia etc)

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Global Project Role

• Develop and direct implementation of global regulatory strategy for assigned projects, along with regional Regulatory Affairs representatives and Regulatory CMC

• Communicate project regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment

• Lead or participate in global regulatory sub-teams

• Lead or participate in FDA and other Health Authority meetings for a project, as required

• Prepare team for FDA and other Health Authority meetings, as required

• Responsible for creation and maintenance of Regulatory Development Plans  and submission strategies to achieve regulatory approvals that meet project needs

• Lead the preparation of high quality regulatory dossiers ensuring compliance with regulatory requirements

• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances

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Key Requirements/Knowledge: 

• Bachelor’s degree in scientific discipline; Advanced scientific degree preferred

• Minimum of 12 years pharmaceutical industry experience with a minimum of 10 years in US and global regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting.

• Regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas, with expertise in Hematology/Oncology or Inflammation/Immunology diseases required;

• Demonstrated experience in strategic planning, preparing and leading IND/NDA submissions

• In depth knowledge of current US and global regulations and guidances essential as they relate to the overall global regulatory strategy

• Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment

• Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously

• Exceptionally keen skills for  attention to detail

• Must be able to innovate, analyze and solve regulatory related problems

• Significant line management experience required

• Demonstrated experience leading, mentoring and building teams

• Domestic and occasional International travel is required

Competencies /Skills

• Demonstrated ability to use scientific and clinical knowledge to conceptualize study designs

• Demonstrated ability to anticipate and resolve problems

• Demonstrated leadership qualities in cross functional project context and direct staff supervision

• Proficiency in data interpretation

• Strong organizational skills

• Clinical project management skills

• Display a willingness to challenge the status quo and take risks

• Excellent skills in oral and written communication, including effective presentation skills to clearly articulates ideas, opinions and information

• Excellent interpersonal skills and ability to communicate effectively across Regulatory Affairs and across the different organization functions

• Translate the organization’s vision and strategies into meaningful regulatory strategy which achieve goals

• Effectively evaluates the benefits and risks associated with moving forward with new regulatory strategies

• Cultivates internal and external networks of people across a variety of functions and locations

• Good listening skills and a strong willingness/desire to help resolve issues faced by others around them

• Allocates resources consistent with strategic priorities

• Anticipates future needs within the function when selecting and developing talent (e.g. develops successors and talent pools for key positions)

• Ability to coach and mentor colleagues required

Prerequisites

• Bachelors in scientific discipline. Advanced scientific degree preferred;

• Minimum of 12 years pharmaceutical industry experience with a minimum of 10 years in US and global regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting.

• Regulatory experience in multiple phases of drug development across various therapeutic areas, with expertise in Hematology/Oncology or Inflammation/Immunology diseases required; Demonstrated leadership in mentoring, building successful goal-oriented teams and supervising staff.

• Prior supervisory experience preferred.

Direct and Indirect Reports:

• US Regional Regulatory Leaders

• Global Regulatory Leaders

Decision Making Authority:

• Roles and Responsibilities

• Resource Allocation

Key Internal/External Partners:

• Global Project Teams

• Global Franchise Teams

• Global Regulatory Franchise Leaders

• Regulatory Sub-teams

• Governance Committees

• US-FDA and other regional Regulatory Health Authorities as applicable

Celgene Leadership Competencies

• Drive Innovation and Results

• Shape Strategy

• Attract and Develop Talent

• Promote Open Communication

• Create Global Mindset

• Demonstrate Adaptability

• Foster Risk Taking

• Foster Teamwork

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Passion for the Patient

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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