Associate Director, Global Regulator Strategy, 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

Pharmaceutical, NeuroscienceIndustries

Requirements

Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry

Responsibilities

Support the preparation of, and participate in / lead (as appropriate), key Health Authority (HA) interactions
Assure consistent positions on common issues are presented to global HA
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

Skills

Regulatory Affairs

Global Regulatory Strategy

Health Authority Interactions

Marketing Applications

Labeling Development

Clinical Protocols

DSURs

Investigator's Brochures

Statistical Analysis Plans

Clinical Trial Applications

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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