Director, CMC Biologics
Oversee management of multiple development and life-cycle management projects of varying priorities and complexities.
Represent Regulatory-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects for Biological products.
Represent BMS at health authority meetings.
Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities.
Develop & communicate strategic direction based on global regulatory guidelines and experience.
Prepare CMC submissions while ensuring thoroughness, completeness, and timeliness.
Review submissions from CMC managers for clarity of both strategic and technical content.
Utilize electronic systems for dossier creation, review, and tracking.
Manage and actively support growth and development of direct reports.
Qualifications Requirements o Minimum BA/BS.
o Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8
years regulatory CMC experience.
Experience with Biologic products preferred.
o Knowledge of CMC regulatory requirements during development and post-approval phases.
o Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
.
o Ability to interact with CMC technical experts regarding process development and analytical issues.
o Ability to identify, communicate and resolve routine/complex issues.
o Ability to identify trends & changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.
o Strong oral and written skills are required.
o Prior management skills preferred.
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501561.
Estimated Salary: $20 to $28 per hour based on qualifications.
Represent Regulatory-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects for Biological products.
Represent BMS at health authority meetings.
Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities.
Develop & communicate strategic direction based on global regulatory guidelines and experience.
Prepare CMC submissions while ensuring thoroughness, completeness, and timeliness.
Review submissions from CMC managers for clarity of both strategic and technical content.
Utilize electronic systems for dossier creation, review, and tracking.
Manage and actively support growth and development of direct reports.
Qualifications Requirements o Minimum BA/BS.
o Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8
years regulatory CMC experience.
Experience with Biologic products preferred.
o Knowledge of CMC regulatory requirements during development and post-approval phases.
o Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
.
o Ability to interact with CMC technical experts regarding process development and analytical issues.
o Ability to identify, communicate and resolve routine/complex issues.
o Ability to identify trends & changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.
o Strong oral and written skills are required.
o Prior management skills preferred.
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501561.
Estimated Salary: $20 to $28 per hour based on qualifications.
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