Senior Specialist, CMC Submission Management at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

5+ years relevant submissions experience
Foundational knowledge of global regulatory practices, submission guidelines and requirements
Assists in the implementation of short- and long-term goals within own work group within RISM
Come prepared with a solution to questions and issues as they arise
Engages relevant stakeholders to help address the problem
Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers
Demonstrates basic presentation skills needed to deliver content to a variety of audiences
Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail
Communicates project status and updates, as appropriate, to relevant stakeholders
Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives
Proposes alternative solutions for submission-related and/or project situations
Seeks to understand stakeholder needs, priorities, working processes, and activities
Understands and embraces the use of specific regulatory systems and associated tools based on area of expertise or job function
Has intermediate-level working knowledge of common desktop software (eg, Microsoft Office Suite, Adobe Acrobat, and SharePoint)
BA/BS degree, science / technology field preferred

Responsibilities

Tracks, collects, and reviews all components for submission to Health Authorities
Perform submission publishing activities
Interacts with responsible parties for quality submission documents for submissions
Facilitate submission team meetings with team support
May participate in focused projects related to their scope of work
Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission)
Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines
Coordinate Initial IND Kick off meeting submission
Coordinate IND, NDA, BLA and Orphan Drug Annual Reports
Develop/Update job aid documents for departmental process
Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist)
Coordinate non-eCTD submissions with International Regulatory Team lead

Skills

CMC Submission Management

Submission Publishing

Regulatory Submissions

IND

NDA

BLA

DSUR

PSUR

CARA

PRISM

eCTD

Global Regulatory Practices

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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