RayzeBio Director of Regulatory Affairs - Clinical/NonClinical at Bristol-Myers Squibb

San Diego, California, United States

Apply Now

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Skills

Key technologies and capabilities for this role

Regulatory StrategyClinical Regulatory AffairsNonclinical Regulatory AffairsRegulatory InteractionsRegulatory Document AuthoringDisease Area KnowledgeStandard of Care AnalysisGlobal Regulatory Lead

Questions & Answers

Common questions about this position

What is the location for this Director of Regulatory Affairs position?

The position is located in San Diego.

What are the basic qualifications required for this role?

Candidates need a Bachelor’s degree or higher, 7 or more years of hands-on regulatory experience, experience with therapeutic and diagnostic radiopharmaceutical product development including radioisotopes like 68Ga and 177Lu, experience with clinical regulatory strategy in prostate cancer, and a record of strong leadership and teamwork.

What key skills are needed for this position?

The role requires excellent written and verbal communication skills, the ability to multi-task and handle pressure while staying highly organized, and being meticulous with detail and precision.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Director position?

A strong candidate will have 7+ years of hands-on regulatory experience, particularly with radiopharmaceuticals and prostate cancer strategies, plus proven leadership in fast-paced cross-functional teams.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free