MANAGER, REGULATORY AFFAIRS at Bristol-Myers Squibb

Rueil-Malmaison, Ile-de-France, France

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Pharmacien with specialization in Regulatory Affairs
At least 1 year of successful experience in Regulatory Affairs, preferably in laboratories with innovative products
Ability to work in a team
Positive and constructive mindset
Adaptability
Proactive with suggestions
Professional English
Mastery of Microsoft Office suite

Responsibilities

Verify and approve promotional documents and medical visit training materials in compliance with regulations; ensure timely submission of advertising visa applications, especially for product launches
Prepare and update risk minimization tools for assigned products; collaborate with internal Pharmacovigilance teams
Monitor product registration in collaboration with international teams, validate packaging materials, and prepare transparency dossiers
Contribute to cross-departmental projects, including assessing regulatory feasibility of innovative BU projects
Provide regulatory support to the International Regulatory Affairs Department for authorizing and monitoring clinical trials implemented by BMS or in collaboration with institutional promoters

Skills

Key technologies and capabilities for this role

Regulatory AffairsPublicité PharmaceutiquePharmacovigilanceGestion des RisquesCode de la Santé PubliqueVisa PublicitéAffaires Réglementaires

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What qualifications and skills are required for the Manager, Regulatory Affairs role?

Candidates must be a Pharmacien with specialization in Regulatory Affairs, have at least 1 year of successful experience in Regulatory Affairs preferably in labs with innovative products, professional English proficiency, mastery of Microsoft Office pack, ease working in a team, positive and constructive mindset, adaptability, and strength in proposing ideas.

What is the company culture like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, and life-changing work in a flexible environment with high-achieving teams, opportunities for growth, and recognition of work-life balance.

What makes a strong candidate for this regulatory affairs manager position?

A strong candidate is a Pharmacien specialized in Regulatory Affairs with at least 1 year of experience in the field, preferably in innovative product labs, along with team collaboration skills, a positive attitude, adaptability, proactive idea generation, professional English, and Microsoft Office proficiency.

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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