Submission Manager at Bristol-Myers Squibb

Warsaw, Masovian Voivodeship, Poland

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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

BA/BS degree, science/technology field preferred
7+ years relevant submissions experience and people management experience
Proficient knowledge of global regulatory practices, submission guidelines and requirements
Collaborates with key stakeholders and resolves cross-functional issues independently and generates solutions by weighing risks and dependencies
Support of other RISM members sharing expertise, providing guidance and serving as a SME
Communicates effectively in English and simplifies complex topics for presentations and workshops
Applies project management methodologies and strategic thinking to define objectives, track progress, and deliver results on increasingly more complex projects
Proficient with desktop software and able to instruct others

Responsibilities

Collaborate with key stakeholders to define IND and marketing submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines
Assess core submission deliverables to ensure compliance, prepare and deliver eCTD submission dossiers for global markets
Drive the execution of the Global Submission Plan for assigned products, collaborating with global teams and proactively monitoring progress to ensure timely health authority submissions
Manage the submission production activities for assigned products including the lifecycle management of applications
Manage the submission production activities for queries, commitments, and other lifecycle management submissions with health authorities
Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams
Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information
Ensure consistency of IND and marketing applications across projects, studies, and countries, aligning with regulatory standards and best practices
Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement
Lead a team of direct reports managing resource and allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation

Skills

eCTD

IND submissions

marketing submissions

regulatory strategy

global submission plan

regulatory compliance

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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