Regulatory Affairs Director
4 days ago
The Director of Regulatory Strategy plays a pivotal role in shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic areas. This leadership position requires deep knowledge of global regulatory environments, strong cross-functional collaboration, and a focus on providing expert guidance to internal teams and external clients.
Key Responsibilities:- Develop and lead innovative regulatory strategies to support the global development, approval, and lifecycle management of clinical programs, ensuring alignment with client goals and regulatory requirements.
- Serve as the primary regulatory expert, advising clients on regulatory pathways, submission strategies, and risk mitigation for drug, biologic, and medical device development.
- Oversee the preparation and submission of regulatory documents, including INDs, NDAs, BLAs, CTAs, MAAs, and other global regulatory filings.
- Lead regulatory interactions with health authorities (e.g., FDA, EMA, PMDA), including pre-submission meetings, scientific advice, and advisory committee meetings.
- Collaborate with internal project teams (clinical, safety, data management, etc.) to ensure regulatory compliance and strategic alignment across all development activities.
- Advanced degree in life sciences (e.g., PhD, PharmD, MS) or equivalent experience in a regulatory or scientific discipline.
- Minimum of 8-10 years of regulatory affairs experience, preferably in a CRO, pharmaceutical, or biotechnology environment.
- Proven track record of success in developing and executing regulatory strategies for global clinical trials and marketing applications.
- Strong knowledge of FDA, EMA, ICH, and other international regulatory guidelines and requirements.
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Regulatory Affairs Director
3 weeks ago
Germantown, Maryland, United States Precigen, Inc Full timeJob Title: Associate Director, Regulatory AffairsJob Summary:Precigen, Inc is seeking a highly motivated and experienced Associate Director/Director, Regulatory Affairs to join our team. This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development. The successful candidate will work closely with the...
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Regulatory Affairs Director
4 weeks ago
Germantown, Maryland, United States Precigen, Inc Full timeJob Title: Associate Director, Regulatory AffairsAbout the Role:Precigen, Inc. is seeking a highly motivated and experienced Associate Director, Regulatory Affairs to join our team. This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development. The successful candidate will participate in the...
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Regulatory Affairs Associate Director
5 days ago
Germantown, Maryland, United States Precigen Full timeJob Title: Associate Director, Regulatory AffairsPrecigen is seeking a highly motivated and experienced Associate Director/Director, Regulatory Affairs to join our team in Germantown, Maryland. This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development.Key Responsibilities:Manage day-to-day...
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Regulatory Affairs Associate Director
5 days ago
Germantown, Maryland, United States Precigen Full timeJob Title: Associate Director, Regulatory AffairsPrecigen is seeking a highly motivated and experienced Associate Director/Director, Regulatory Affairs to join our team. This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development.Key Responsibilities:Manage day-to-day Regulatory Affairs activities...
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Regulatory Affairs Director
3 weeks ago
Germantown, Maryland, United States NSF International Full timeJob Title: Director of Regulatory StrategyNSF International is seeking a highly skilled Director of Regulatory Strategy to join our team. As a key member of our Regulatory Affairs department, you will be responsible for shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic...
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Regulatory Affairs Director
5 days ago
Germantown, Maryland, United States NSF Full timeJob DescriptionThe Director of Regulatory Strategy is a critical role that requires a deep understanding of global regulatory environments and a strong ability to collaborate with cross-functional teams. This leadership position is responsible for shaping and executing regulatory strategies for clinical development programs and regulatory submissions across...
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Regulatory Affairs Director
3 weeks ago
Germantown, Maryland, United States NSF International Full timeJob Title: Director of Regulatory StrategyThe Director of Regulatory Strategy plays a critical role in shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic areas at NSF International.This leadership position requires deep knowledge of global regulatory environments, strong...
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Associate Director, Quality Assurance
4 weeks ago
Germantown, Maryland, United States Precigen, Inc Full timeJob Title: Associate Director, Quality AssurancePrecigen, Inc. is seeking a highly skilled and motivated Associate Director, Quality Assurance to join our team. As a key member of our Quality Assurance department, you will be responsible for leading the development, implementation, and execution of Quality Systems for Precigen.Key Responsibilities:Develop...
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Rehabilitation Director
1 month ago
Germantown, Maryland, United States Consonus Healthcare Services Full timeLead Rehabilitation Team with Consonus Healthcare ServicesAs an Assistant Director of Rehabilitation, you will be responsible for leading a team of dedicated therapists in implementing evidence-based practices and cutting-edge modalities to achieve outstanding outcomes for patients. This role requires strong leadership and organizational skills to facilitate...
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Rehabilitation Director
4 weeks ago
Germantown, Maryland, United States Consonus Healthcare Services Full timeAbout the RoleWe are seeking a highly skilled and experienced Assistant Director of Rehabilitation to join our team at Consonus Healthcare Services. As a key member of our leadership team, you will be responsible for leading and nurturing a team of dedicated therapists, managing financial goals, and ensuring regulatory compliance.Key ResponsibilitiesLead and...
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Rehabilitation Director
3 days ago
Germantown, Maryland, United States Consonus Rehab Full timeAbout the RoleWe are seeking a highly skilled and experienced Rehabilitation Director to join our team at Consonus Healthcare. As a key member of our leadership team, you will be responsible for leading and nurturing a team of dedicated therapists, managing financial goals, and ensuring regulatory compliance.Key ResponsibilitiesLead and develop a team of...
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Rehabilitation Director
1 month ago
Germantown, Maryland, United States Consonus Healthcare Services Full timeLead Rehabilitation Team at Consonus Healthcare ServicesAs an Assistant Director of Rehabilitation at Consonus Healthcare Services, you will have the opportunity to lead a dynamic team of therapists and implement evidence-based practices to achieve outstanding patient outcomes.Key Responsibilities:Lead and nurture a team of dedicated therapists to provide...
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Associate Director, Quality Assurance
2 days ago
Germantown, Maryland, United States Precigen, Inc Full timeJob OverviewPrecigen, Inc. is a biopharmaceutical company dedicated to advancing gene and cell therapies using precision technology. We are seeking a highly motivated and skilled Associate Director, Quality Assurance, to lead the development, implementation, and execution of Quality Systems for our organization.The successful candidate will manage GxP...
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Rehabilitation Director
1 month ago
Germantown, Maryland, United States Consonus Healthcare Services Full timeLead Rehabilitation Team at Consonus Healthcare ServicesAs an Assistant Director of Rehabilitation at Consonus Healthcare Services, you will have the opportunity to lead a dynamic team of therapists and implement evidence-based practices to achieve outstanding patient outcomes.Key Responsibilities:Lead and nurture a team of dedicated therapists to provide...
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Rehabilitation Director
3 weeks ago
Germantown, Maryland, United States Consonus Healthcare Services Full timeAbout the RoleWe are seeking an experienced Assistant Director of Rehabilitation to join our dynamic team at Consonus Healthcare Services. As a key member of our leadership team, you will be responsible for leading a cohesive team of therapists and implementing evidence-based practices to achieve outstanding outcomes for our patients.Key ResponsibilitiesLead...
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Rehabilitation Director
4 weeks ago
Germantown, Maryland, United States Consonus Healthcare Services Full timeAbout the RoleWe are seeking a highly skilled and experienced Assistant Director of Rehabilitation to join our dynamic team at Consonus Healthcare Services.Key ResponsibilitiesLead and nurture a team of dedicated therapists to deliver exceptional patient care.Manage financial goals and ensure regulatory compliance in our rehabilitation services.Apply a...
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Program Director
2 weeks ago
Germantown, Maryland, United States EchoStar Full timeJoin EchoStar's Team as a Program Director - AviationEchoStar Corporation, a leading global provider of satellite communication solutions, is seeking a highly skilled Program Director - Aviation to lead the development, launch, and service delivery phases of large aviation programs in our Hughes Network Systems division.About the RoleThis is an exciting...
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Preschool Area Director
4 days ago
Germantown, Maryland, United States Chesterbrook Academy Full timeJob Title: Preschool Area PrincipalAre you a seasoned education professional looking for a challenging leadership role? Do you have a passion for early childhood education and a proven track record of success in school administration?Job Summary:We are seeking an experienced Preschool Area Principal to lead our team of educators and support staff in...
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MRI Technologist
2 weeks ago
Germantown, Maryland, United States Outpatient Imaging Affiliates Full timeJob SummaryUnder the direction of the Radiology Medical Director, the MRI Technologist will perform routine to complex magnetic resonance procedures and related techniques, producing images at the request of and for interpretation by a licensed independent practitioner.Key ResponsibilitiesPerforms MRI procedures and related techniques, producing high-quality...
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MRI Technologist
2 days ago
Germantown, Maryland, United States Outpatient Imaging Affiliates Full timeJob SummaryUnder the direction of the Radiology Medical Director, the MRI Technologist performs routine to complex magnetic resonance procedures and related techniques, producing images at the request of and for interpretation by a licensed independent practitioner.Ensures services are performed in a safe environment in accordance with established guidelines...