Senior Director, Global Regulatory Lead Neuroscience at Bristol-Myers Squibb

Princeton, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in neurology, neuromuscular diseases or neuropsychiatry drug development strongly preferred
8-12 years pharmaceutical industry experience, including 6-8 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 expertise 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

Responsibilities

Key member of the GRSP Extended Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area
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 Lead and US Regional Regulatory Lead 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

Skills

Regulatory Strategy

Global Regulatory Affairs

Neuroscience

Therapeutic Area Strategy

Due Diligence

Business Development

US Regulatory

International Regulatory

Product Development Plans

Regulatory Operations

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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