RayzeBio Director of Regulatory Affairs - Clinical/NonClinical

San Diego, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Candidates must possess a Bachelor's degree or higher and at least 7 years of hands-on regulatory experience. Experience with therapeutic and diagnostic radiopharmaceutical product development, including familiarity with specific radioisotopes, is required. Experience with clinical regulatory strategy in prostate cancer and a record of strong leadership and teamwork in a fast-paced, cross-functional environment are also necessary. Excellent written and verbal communication, organizational skills, attention to detail, proficiency in MS Office, and strong interpersonal skills are essential.

Responsibilities

The Director of Regulatory Affairs will serve as a Global Regulatory Lead for an RPT program, developing clinical and nonclinical regulatory strategies for therapeutic and diagnostic products, including global regulatory interactions. This role involves authoring regulatory documents, staying current with disease areas and regulatory landscapes, and maintaining relationships with regulators. Responsibilities include leading the preparation and submission of various regulatory filings such as INDs and marketing applications, and preparing for Health Authority Interactions.

Skills

Regulatory Strategy

Clinical Regulatory Affairs

Nonclinical Regulatory Affairs

Regulatory Interactions

Regulatory Document Authoring

Disease Area Knowledge

Standard of Care Analysis

Global Regulatory Lead

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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