BRIDGE Communications Inc.
Senior Director, Regulatory Affairs - CMC at Bristol-Myers Squibb
BRIDGE Communications Inc., Indianapolis, Indiana, us, 46262
Overview
Senior Director, Regulatory Affairs - CMC (Manufacturing) at RayzeBio, a Bristol Myers Squibb company. Location: Indianapolis, IN. Full time. Reports to the Head of Regulatory Affairs and oversees CMC regulatory functions at the Indianapolis manufacturing facility. Responsibilities and required experience are commensurate with the role. Responsibilities
Work with the Indianapolis facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to provide on-site regulatory decision making and support for RayzeBio-manufactured radiopharmaceuticals, generating documentation for INDs, IMPDs, DMFs, NDAs, and MAAs.
Lead the development and execution of global CMC regulatory strategies for activities at the Indianapolis manufacturing facility.
Develop, compile, maintain, and review facility DMFs and/or author facility-based Quality Modules in regulatory submissions (e.g., IND, IMPD, NDA, MAA) for global Health Authority submissions in compliance with standards.
Ensure CMC documentation (protocols, reports, validation activities, specifications, analytical methods, batch records, etc.) meet regulatory standards to support development, process validation, tech transfer, and facility controls.
Prepare Health Authority responses and background packages, including leading/participating in Health Authority meetings.
Author and prepare submissions for post-approval manufacturing changes (annual reports, CBEs, PAS, supplements).
Independently manage and prioritize multiple complex projects, programs, and workload.
Manage and maintain strong working relationships with site teams and cross-functional groups; participate in and/or lead multifunctional teams.
Manage Regulatory Affairs CMC staff.
Assess manufacturing Change Controls for global impact and guide technical teams on global change management.
Provide additional ad hoc Regulatory-CMC support to RayzeBio manufacturing team.
Research and analyze current US and international regulations and guidance.
Participate with Global Regulatory Leads to develop content of container labels.
Communicate critical issues to Leadership.
Basic Qualifications
Bachelor’s degree with 10+ years of hands-on regulatory CMC experience OR an advanced degree with at least 7 years of hands-on regulatory CMC experience.
Experience with independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections.
Experience providing on-site regulatory strategy in collaboration with facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to generate documentation leading to IND, IMPD, DMF, NDA and MAA applications.
Understanding of phase-appropriate data requirements for regulatory filings.
Experience with aseptic processing.
Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
Preferred
Radiopharmaceutical experience with diagnostics and therapeutics.
Skills
Highly organized, with the ability to multitask and handle pressure well.
Meticulous with detail and precision.
Ability to think through a project of diverse complexity and execute independently from start to finish.
Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, Teams) and video conferencing.
Strong communication and interpersonal skills.
Assertive, proactive, professional, and confident.
Excellent professional ethics and integrity.
Flexibility to adapt in a cross-functional and dynamic environment.
Compensation and Benefits
The starting compensation for this job ranges from $241,768 to $293,000 plus incentive cash and stock opportunities (based on eligibility). Final compensation is determined based on demonstrated experience. Eligibility for benefits varies by job and location. For more on benefits, visit the careers site. Benefits include Medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, travel protection, paid holidays, vacation, volunteer days, leave options, and other perks as outlined by the plans in effect. Other notes: On-site protocol and accommodations, equal employment opportunity statement, vaccination recommendations, and data privacy information are included as part of the role documentation. On-site Protocol
BMS occupancy structure determines where work is performed: site-essential (onsite 100%), site-by-design (hybrid possible with at least 50% onsite), field-based and remote-by-design (travel to meet and represent the company as required). BMS is committed to accessibility and reasonable accommodations in recruitment and employment. Applicants may request accommodations prior to accepting an offer by contacting adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for the full Equal Employment Opportunity statement. BMS encourages vaccination and boosters for COVID-19 as part of well-being and community health. BMS may consider applicants with arrests or convictions as permitted by law. If located in Los Angeles County, additional information is available on the provided page. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Senior Director, Regulatory Affairs - CMC (Manufacturing) at RayzeBio, a Bristol Myers Squibb company. Location: Indianapolis, IN. Full time. Reports to the Head of Regulatory Affairs and oversees CMC regulatory functions at the Indianapolis manufacturing facility. Responsibilities and required experience are commensurate with the role. Responsibilities
Work with the Indianapolis facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to provide on-site regulatory decision making and support for RayzeBio-manufactured radiopharmaceuticals, generating documentation for INDs, IMPDs, DMFs, NDAs, and MAAs.
Lead the development and execution of global CMC regulatory strategies for activities at the Indianapolis manufacturing facility.
Develop, compile, maintain, and review facility DMFs and/or author facility-based Quality Modules in regulatory submissions (e.g., IND, IMPD, NDA, MAA) for global Health Authority submissions in compliance with standards.
Ensure CMC documentation (protocols, reports, validation activities, specifications, analytical methods, batch records, etc.) meet regulatory standards to support development, process validation, tech transfer, and facility controls.
Prepare Health Authority responses and background packages, including leading/participating in Health Authority meetings.
Author and prepare submissions for post-approval manufacturing changes (annual reports, CBEs, PAS, supplements).
Independently manage and prioritize multiple complex projects, programs, and workload.
Manage and maintain strong working relationships with site teams and cross-functional groups; participate in and/or lead multifunctional teams.
Manage Regulatory Affairs CMC staff.
Assess manufacturing Change Controls for global impact and guide technical teams on global change management.
Provide additional ad hoc Regulatory-CMC support to RayzeBio manufacturing team.
Research and analyze current US and international regulations and guidance.
Participate with Global Regulatory Leads to develop content of container labels.
Communicate critical issues to Leadership.
Basic Qualifications
Bachelor’s degree with 10+ years of hands-on regulatory CMC experience OR an advanced degree with at least 7 years of hands-on regulatory CMC experience.
Experience with independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections.
Experience providing on-site regulatory strategy in collaboration with facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to generate documentation leading to IND, IMPD, DMF, NDA and MAA applications.
Understanding of phase-appropriate data requirements for regulatory filings.
Experience with aseptic processing.
Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
Preferred
Radiopharmaceutical experience with diagnostics and therapeutics.
Skills
Highly organized, with the ability to multitask and handle pressure well.
Meticulous with detail and precision.
Ability to think through a project of diverse complexity and execute independently from start to finish.
Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, Teams) and video conferencing.
Strong communication and interpersonal skills.
Assertive, proactive, professional, and confident.
Excellent professional ethics and integrity.
Flexibility to adapt in a cross-functional and dynamic environment.
Compensation and Benefits
The starting compensation for this job ranges from $241,768 to $293,000 plus incentive cash and stock opportunities (based on eligibility). Final compensation is determined based on demonstrated experience. Eligibility for benefits varies by job and location. For more on benefits, visit the careers site. Benefits include Medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, travel protection, paid holidays, vacation, volunteer days, leave options, and other perks as outlined by the plans in effect. Other notes: On-site protocol and accommodations, equal employment opportunity statement, vaccination recommendations, and data privacy information are included as part of the role documentation. On-site Protocol
BMS occupancy structure determines where work is performed: site-essential (onsite 100%), site-by-design (hybrid possible with at least 50% onsite), field-based and remote-by-design (travel to meet and represent the company as required). BMS is committed to accessibility and reasonable accommodations in recruitment and employment. Applicants may request accommodations prior to accepting an offer by contacting adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for the full Equal Employment Opportunity statement. BMS encourages vaccination and boosters for COVID-19 as part of well-being and community health. BMS may consider applicants with arrests or convictions as permitted by law. If located in Los Angeles County, additional information is available on the provided page. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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