Associate Director- Established Brands Regulatory Lead at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Scientific background, Ph.D., M.D., PharmD, M.S. in Pharmacy or Life Sciences or equivalent professional experience
10+ years overall pharma experience

Responsibilities

Lead the regulatory strategy for assigned Established Brands assets and ensure the maintenance of marketing authorizations (MAs) globally through collaboration with regional and country regulatory leads
Represent GRS at the Established Brands Global Program Team (GPT)
Support portfolio optimization (study terminations, product and SKU deletion)
Identify and escalate regulatory risks, ensuring seamless collaboration across teams to drive successful regulatory outcomes
Review Clinical Study Reports and other relevant documents, provide content to Safety Aggregate Reports (DSUR, PSUR/PBRER, Annual Report), and to HA requests/responses
Lead cross-functional rapid response teams to define response strategy and ensure that HA deadlines are met
Oversee the lifecycle of marketed products, ensuring compliance with global/regional regulatory requirements (e.g., renewals, label updates, and safety reports) and ensure regulatory correspondence, postmarketing requirements and commitments are addressed and tracked in Verity
Proactively prioritize and complete multiple projects within established deadlines
Provide regulatory strategic guidance and oversight for deletion proposals put forth by the Worldwide Established Brands Steering Committee (WWEB SC) and transition of assets from In-line/Key Brand to an Established Brand
Work with the Regulatory Divestiture Lead on proposed EB divestiture assessments and support transition to buyer
Understand the regulatory landscape and identify potential issues early, proactively resolve them, and escalate as necessary
Collaborate with EBMT, as well as Enterprise-wide colleagues in Global Development and Pharmaceutical Supply (GPS), Commercial, Legal, and Medical organizations to ensure the regulatory strategy supports global and regional needs
Build and maintain productive relationships with internal teams to ensure the smooth execution of regulatory activities
Maintain awareness of evolving FDA, EMA and international regulations and interpretation, competitive landscape, regulatory precedents, and work cross-functionally to implement those evolved regulations for the assigned projects

Skills

Regulatory Strategy

Marketing Authorizations

Global Regulatory Compliance

Label Updates

Safety Reports

DSUR

PSUR

PBRER

Clinical Study Reports

Risk Management

Portfolio Optimization

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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