Manager Regulatory Operations

3 weeks ago

Dublin, Dublin City, Ireland Bristol-Myers Squibb Full time

Manager Regulatory Operations page is loaded

Manager Regulatory Operations

Apply locations Dublin - IE time type Full time posted on Posted 16 Days Ago job requisition id R1588621

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.

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 Role

The Regulatory Operations Manager is responsible for all regulatory support activities within External Manufacturing to ensure that the manufacture of products by Contract Manufacturing Organizations (CMOs) is aligned with the appropriate regulatory dossiers.

Key Duties and Responsibilities:

  • Develop and manage appropriate business processes to support Regulatory Dossier Management for products supported by External Manufacturing
  • Manage the notification of Change Control approvals and regulatory renewals to CMOs as appropriate, to ensure that the CMO has the most up-to-date regulatory dossiers
  • Manage a process to ensure appropriate batch restrictions are applied in the case of change controls where regulatory approvals are required
  • Manage regulatory documentation requests to support filings, updates, annual reports renewals and Health Authority (HA) requests
  • Review relevant Chemistry, Manufacturing and Controls (CMC) sections of new drug applications (NDA's) and market authorisation applications (MAAs) and provide support for filings
  • Provide Good Manufacturing Practice (GMP) and Regulatory training as required
  • Participate in other Quality Assurance (QA) supporting activities as required (e.g. internal audits, site regulatory inspections, Annual Product Quality Reviews (APQR's), quality risk management)
  • Manage the follow-up and close out of regulatory actions associated with External Manufacturing (ExM) Change Controls

What's important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

  • Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
  • Innovation: We pursue disruptive and bold solutions for patients.
  • Urgency: We move together with speed and quality because patients are waiting.
  • Accountability: We all own BMS' success and strive to be transparent and deliver on our commitments.
  • Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
  • Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

Why you should apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You'll get a competitive salary and a great benefits package

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.

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.

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