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Global Regulatory Sciences Director
1 month ago
Bristol Myers Squibb is a global biopharma leader that transforms patients' lives through science. We are driven by a passion for innovation, fueled by our commitment to advancing the field of healthcare.
About the Role
The CMC Regulatory Associate Director, Biologics plays a pivotal role in content development, compilation, maintenance, and review of the Quality Module for regulatory submissions supporting biologics products. This position serves as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). Key responsibilities include assessing Manufacturing Change Controls for global impact and guiding technical teams on practical aspects of global change management.
Key Responsibilities:
- Develop and maintain quality systems and processes to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Provide guidance and support to technical teams on global change management.
- Assess manufacturing change controls for global impact and develop strategies to mitigate risks.
Requirements and Qualifications
To be successful in this role, you will need:
- A bachelor's degree in a relevant field such as life sciences, chemistry, or engineering.
- At least 8 years of experience in regulatory affairs, with a focus on biologics.
- Strong knowledge of regulatory requirements and industry standards.
- Excellent communication and collaboration skills.
Salary Range: $180,000 - $220,000 per annum
Benefits:
- Comprehensive health insurance package.
- Retirement savings plan with company match.
- Flexible work arrangements, including remote work options.
- Professional development opportunities and training programs.
About Bristol Myers Squibb
We are committed to creating an inclusive and diverse workplace where employees can thrive. Our mission is to transform patients' lives through science, and we believe that our employees are the driving force behind this mission. If you are passionate about making a difference in the lives of patients and have the skills and expertise to succeed in this role, we encourage you to apply.
