Associate Director, Global Regulatory Sciences-Cmc

6-10 years

Not Disclosed

Hyderabad New Brunswick

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us

Challenging. Meaningful. Life-changing. These aren’t words 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 breakthroughs in cell therapy, this is work that transforms patients' lives and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving, diverse teams. 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. Read more: careers.bms.com/working-with-us.

Position Summary / Objective

The CMC Regulatory Associate Director, Biologics is responsible for developing, compiling, maintaining, and reviewing the Quality Module for regulatory submissions to support biologics products. This includes clinical trial applications, new marketing applications, HA responses and background packages (including participating in or leading HA meetings), and post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics serves as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS), assessing Manufacturing Change Controls for global impact and guiding technical teams on practical aspects of global change management.

Position 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.
Provide strategic guidance/input related to current regulatory requirements and expectations for small molecule marketing applications, clinical trial applications, and lifecycle changes to marketed products.
Manage and prioritize multiple complex projects independently.
Interface with Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from a supervisor on complex topics.
Identify, communicate, and propose resolutions to routine/complex issues.
Interpret global regulations and guidance, identifying 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, ensuring thoroughness, completeness, and timeliness, including the creation and maintenance of strategy documents.
Manage relationships with diverse teams.
Utilize electronic systems for dossier creation and tracking.

Degree Requirements

Minimum BA/BS Degree.

Experience Requirements

7-10+ years of pharmaceutical industry experience, including multi-disciplined experience.
6+ years of CMC regulatory strategy experience.
Knowledge of CMC regulatory requirements during development and post-approval, with experience in 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 in 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, ensuring thoroughness, accuracy, and timeliness.
Ability to interpret global regulations and guidance.

Key Competency Requirements

Strong oral and written communication skills.
Proficiency with electronic systems.

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. 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 assigned is determined by the nature and responsibilities of the 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.
Field-based and remote-by-design roles require the ability to physically travel to visit customers, patients, or business partners and attend meetings on behalf of BMS as directed.

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 before 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 adastaffingsupport@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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