Associate Director Commercial Regulatory Affairs (Hybrid) at Bristol-Myers Squibb

Madison, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

BS required; advanced degree preferred (MS, PhD, PharmD, JD)
Minimum of 3-5 years Regulatory promotional review or related; 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products
Strong interest in FDA advertising and promotion regulations including guidance(s)
Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
Proven aptitude to analyze and interpret efficacy and safety data

Responsibilities

Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
Provides solution-oriented and innovative advice to meet the company’s objectives and goals
Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions
Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidances
Ensure regulatory compliance with subpart E/H and 2253 regulations
Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion
Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
Provide input on process improvement and BMS guiding principles as needed
Engages with colleagues within the department to help support them in their roles and development
Provide direct management to individuals depending on assignment
Proactively seeks opportunities to learn and develop leadership skills

Skills

Regulatory Affairs

FDA Regulations

PhRMA Guidelines

FTC Guidelines

Promotional Materials Review

Risk Assessment

Advertising Compliance

Promotional Labeling

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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