Associate Director, CMC Regulatory Affairs
: Job Details :

Associate Director, CMC Regulatory Affairs

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program and provides compliance documents to support Health Authority submissions.

The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research.
• Independently provide strategic guidance/input related to current regulatory requirements and expectations for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
• Independently manage and prioritize multiple complex projects.
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics.
• Identify, communicate, and propose resolutions to routine/complex issues.
• Interpret global regulations and guidance. Identify regulatory opportunities and risks.
• Anticipate and communicate possible regulatory paradigm shifts.
• Participate in product fact-finding meetings.
• Review and provide regulatory assessments on change controls.
• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documents.
• Manage relationships with diverse teams.
• Utilize electronic systems for dossier creation and tracking.

Requirements

• Minimum BA/BS Degree.
• 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy.
• Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products.
• Knowledge of pharmaceutical development, including drug substance, drug product, and analytical methods.
• Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects, and work independently.
• Ability to identify, communicate, and resolve complex issues.
• Prepare and manage filings and ensure thoroughness, accuracy, and timeliness.
• Ability to interpret global regulations and guidance.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients' lives through science,” every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

• Site-essential roles require 100% of shifts onsite at your assigned facility.
• Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
• For field-based and remote-by-design roles, the ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ...@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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