Regulatory (CMC) Compliance Manager

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Position
Regulatory Compliance Manager, External Manufacturing
Department
Quality Systems
Job Function
Reporting to the Associate Director, Global Quality Systems, the Regulatory Compliance Manager is responsible for all regulatory support activities within External Manufacturing to ensure that the manufacture of products by CMO's is aligned with the appropriate regulatory dossiers.
Responsibilities

• Manage Operations

• 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.
• Develop and 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, renewals and HA requests.
• Review relevant CMC sections of NDA's and MAAs and provide support for filings.
• Provide GMP and Regulatory training as required.

• Support Regulatory inspections of External Manufacturing.
• Review ExM CC to determine if they meet the requirements for level 1 or level 2 changes. Where level 2 changes are identified, provide a SME opinion of the regulatory impact of the change.
• Manage the follow-up and close out of regulatory actions associated with ExM Change Controls.

Manage People/Team work

• Build and manage a regulatory team to support External Manufacturing.
• Build effective working relationships with CMOs and the Virtual Plant teams as appropriate.
• Set and update work objectives for direct reports using the Company Performance Connection process
• Provide regular feedback and coaching

Designee Responsibilities
This position can be a designee for the Associate Director, Global Quality.

Required Competencies
Essential
In addition to the core BMS competencies,the Global Quality Systems Manager will have following competencies:

• In-depth understanding of the International Regulatory Requirements post-approval
• Business Knowledge/understanding of External Manufacturing.
• Leadership and Management Skills.
• Excellent communication skills.
• Understanding of cGMP principles pertaining to API and Drug Product pharmaceutical manufacture.
• Demonstrates expert knowledge of FDA, ICH and BMS corporate cGMP policies and guidelines.
• Ability to manage cross functional projects and meet tight timelines/deadlines.
• Strong Technical writing ability.
• Openness to change, receptive to new ideas

Required Qualification(s) and Desired Experience

• BSc / MSc in chemistry or related disciplines.
• Preferable to have experience in QA and Regulatory.
• Knowledge / appreciation of other site operations such as QC, Materials, MT and manufacturing.

BMS BioPharma Behaviors

• The qualified candidate demonstrates characteristics of our BMS BioPharma Behaviors.

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 the resources to pursue their goals, both at work and in their personal lives.