Associate Director, Global Regulatory Sciences – CMC,Small Molecule

7 months ago

Hyderabad, India Bristol Myers Squibb Full time

Working with Us
Challenging. 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.

Position Summary

The CMC Regulatory Associate Director, Small Molecule is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Small Molecule 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, Small Molecule will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product Development and Supply (GPS). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management. The position may include direct report(s).

Key Responsibilities

Participate 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 expectation for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products, including guidance/input in support of direct reports and their projects.

Independently manage and prioritize multiple complex projects, including support of direct reports and their projects.

May interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.

Identify, communicate and propose resolutions to routine/complex issues

Interpret global regulations and guidance. Identify regulatory opportunity and risks.

Anticipate and communicate possible regulatory paradigm shifts.

May support deviation investigations

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.

Manage and actively support growth and development of any/all direct reports.

Strong oral and written skills. 

Proficient with electronic systems.

Prior management skills and / or experience preferred.

Qualifications & Experience
 

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 biologic 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.
 

Uniquely Interesting Work, Life-changing Careers
With 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 . Visit 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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