Regulatory Affairs Director
1 week ago
MaxCyte Inc is a leading company in the field of cell and gene therapy. We are seeking an experienced Regulatory Affairs Director to head our Regulatory function.
The ideal candidate will have at least 8-10 years of leadership experience and 8 years of relevant regulatory experience within biologics drug development, preferably in cell and gene therapy.
Key Responsibilities:
- Maintain current regulatory filings and interpret regulations to support interdepartmental project teams
- Update existing Master Files in various countries and create effective regulatory strategies
- Partner with cross-functional teams to ensure timely and strategic submissions
- Support projects and product teams to identify and address regulatory risks
- Develop and implement regulatory processes and procedures
- Interface with consultants, auditors, and regulatory advisors
Requirements:
- BS/BA in science or engineering field; advanced degrees preferred
- Solid understanding of global regulatory and legal liability issues
- Hands-on experience in global DMF filings and compliance
- Strong verbal and written communications skills
- Proven track record of success in problem solving and developing risk-based solutions
- Experience working on cross-functional teams
The estimated salary for this role is $220,000 per year, based on industry standards and market trends.
MaxCyte offers a comprehensive benefits package, including health, dental, vision, life, and disability insurance, as well as generous time off.
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Regulatory Affairs Lead
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Rockville, Maryland, United States MaxCyte Inc Full timeMaxCyte Inc is a leading company in the field of biologics drug development, particularly in cell and gene therapy. We are currently seeking a highly skilled Regulatory Affairs Lead to join our team.The salary range for this role is $210,000 - $229,000 per year, with opportunities for annual bonuses and equity participation. Our comprehensive benefits...
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Rockville, Maryland, United States MaxCyte Inc Full timeJob OverviewThis is a challenging role that requires leadership skills and expertise in regulatory affairs to head the Regulatory function at MaxCyte. The ideal candidate will develop and implement regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements.About UsMaxCyte Inc. is a...
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