Executive Director Regulatory Affairs Team Leader - Jersey City, United States - CLevelCrossing

Description

Executive Director Regulatory Affairs Team Leader

Location
Jersey City, NJ, United States
Posted on
Jul 15, 2020
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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.


Position:
Executive Director, Regulatory Affairs Team Leader


Supervisor:
Vice President, Regulatory Affairs


Department:
Global Regulatory Affairs

Prerequisites

Bachelors in scientific discipline.

Advanced scientific degree preferred;

Minimum of 15 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.


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 US 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.

Core Responsibilities:
US 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)

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


Key Requirements/Knowledge:
Bachelor's degree in scientific discipline; Advanced scientific degree preferred

Minimum of 15 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


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
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.

Company:
Bristol-Myers Squibb


Req Number:
R1526212_EN


Updated:
:00:00.000 UTC


Location:
Jersey City,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:
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