Senior Director, Regulatory Affairs CMC
1 month ago
We are seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team at Replimune, Inc. This role will be responsible for developing and executing CMC regulatory strategies and activities, ensuring timely preparation, review, and submission of CMC documents to regulatory authorities.
Key Responsibilities:- Develop and execute CMC regulatory strategies and activities to ensure compliance with applicable regulatory requirements.
- Oversee the development and implementation of global regulatory strategies, including the preparation, review, and submission of CMC documents to regulatory authorities.
- Collaborate with development partners, regulatory subject matter experts, and other stakeholders to ensure a fully integrated regulatory strategy.
- Manage external regulatory consultants and project deadlines to ensure timely completion of regulatory submissions.
- Ensure compliance with company standards and applicable US and international regulations.
- A minimum of 15 years of experience in the Pharmaceutical/Biotech Industry, with 10+ years in a CMC Regulatory Affairs capacity.
- Strategic leadership experience, with a proven track record of building, managing, and developing teams.
- Professional knowledge and skills working with solid tumor oncology therapeutics, with biologic, gene therapy, or vaccine experience preferred.
- Excellent written and verbal communication skills, with the ability to interact directly with global regulatory agencies.
- Strong interpersonal, organizational, and time management skills, with attention to detail.
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
We are an Equal Opportunity Employer and welcome applications from diverse candidates.
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Director, Regulatory Project Management Lead
1 month ago
Woburn, Massachusetts, United States Ultragenyx Pharmaceuticals Full timeUnlock Your Potential in Rare Disease MedicineAt Ultragenyx Pharmaceuticals, we're on a mission to revolutionize the treatment of rare diseases. As a Director, Regulatory Project Management Lead, you'll play a critical role in driving our pipeline of innovative therapies into the hands of patients who need them most.Key Responsibilities:Partner with...
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Senior Director/VP of Sales-Diagnostics
1 month ago
Woburn, Massachusetts, United States Curiox Biosystems Full timeJob Title: Senior Director/VP of Sales-DiagnosticsCuriox Biosystems is a pioneering life science technology company dedicated to automating and standardizing sample preparation for cell analysis with its innovative Curiox C-FREETM technology.We are seeking a dynamic and experienced Senior Director or Vice President of Sales – Diagnostics to lead and expand...
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Senior Director of Product Management
1 month ago
Woburn, Massachusetts, United States MedAdvisor International Pty Ltd Adheris Health Full timeAbout the RoleThis position will focus on designing and implementing a clear strategic vision for all MedAdvisor's U.S. products, ensuring alignment with the overall company strategy. The Senior Director, Product will bring deep experience and understanding of the product development life cycle, product management, and user-centered design. This role...
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Director of Employee Engagement
4 weeks ago
Woburn, Massachusetts, United States American Tower Full timeJob DescriptionThe TeamWe are seeking a Director of Employee Engagement to join American Tower's Corporate Human Resources organization. Day to day, you will lead employee communications for American Tower's largest global division, U.S. Tower (UST). You will deepen employee engagement through strategic and creative multi-year communications plans and...
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Senior Director, Financial Planning and Analysis
4 weeks ago
Woburn, Massachusetts, United States EHR SERVICES LLC Full timeCovaris, a leading biotech company, is seeking an experienced Senior Director, FP&A, to drive the company's financial reporting, analysis, and strategic planning.Key Responsibilities:Manage global financial operations, including income statements, balance sheets, and cash flows.Collaborate closely with senior executives to drive critical financial...
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Senior Director, Financial Planning and Analysis
4 weeks ago
Woburn, Massachusetts, United States EHR SERVICES LLC Full timeCovaris, Inc. is a leading biotech company that has pioneered the Adaptive Focused Acoustics technology platform, revolutionizing pre-analytical sample preparation in Genomics, Proteomics, and Epigenomics research. We are seeking an experienced Senior Director, FP&A, with a proven track record of financial acumen and leadership skills to drive our financial...
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Nursing Director
1 month ago
Woburn, Massachusetts, United States Associated Home Care Full timeJob SummaryAssociated Home Care seeks a seasoned Director of Nursing to lead our team in delivering exceptional home health care services. The ideal candidate will have a strong clinical background, excellent leadership skills, and a passion for quality patient care.Key ResponsibilitiesDevelop and implement policies and procedures to ensure high-quality care...
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Director of Product Engineering and Innovation
1 month ago
Woburn, Massachusetts, United States Fusion Optix Full timeJob Title: Director of Product Engineering and InnovationFusion Optix is seeking a visionary leader to drive the development of cutting-edge LED lighting products. As the Director of Product Engineering and Innovation, you will be responsible for leading a high-performing engineering team in driving innovative processes and methodologies to enhance product...
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Senior Mechanical Engineer
4 weeks ago
Woburn, Massachusetts, United States GCR Professional Services Full timeWe are seeking a highly skilled Senior Mechanical Engineer to lead the development of next-generation robotic systems. This role is critical to the success of our cutting-edge products and our overall business growth.Key Responsibilities:Develop and implement innovative mechanical systems for robotic applications.Lead a team of engineers to design, test, and...
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Woburn, Massachusetts, United States Marquis Health Services Full timeJob SummaryWe are seeking an experienced Regional Director of Case Management and Reimbursement to support our MDS reimbursement & Care Navigation teams in our Massachusetts market. The Regional Director of Case Management and Reimbursement will work under the direction of the VP of Case Management. The Regional Director of Case Management and Reimbursement...
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Director of Nursing Operations
1 month ago
Woburn, Massachusetts, United States Associated Home Care Full timeJob OverviewAssociated Home Care is seeking a highly skilled and experienced Director of Nursing to lead our team in delivering exceptional patient care and services. As a key member of our leadership team, you will be responsible for overseeing the daily operations of our nursing department, ensuring compliance with regulatory requirements, and driving...
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Strategic Partnerships Director
4 weeks ago
Woburn, Massachusetts, United States MedAdvisor International Pty Ltd Adheris Health Full timeAbout the JobThe Senior Director, Strategic Partnerships at MedAdvisor Solutions will lead the development and execution of the company's partnership strategy, aligning key initiatives with long-term business objectives. This role is responsible for identifying and nurturing high-value relationships with external partners, driving collaboration across...
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Senior Financial Planning and Analysis Manager
4 weeks ago
Woburn, Massachusetts, United States Sirtex Full timeJob SummaryWe are seeking a highly skilled Senior Financial Planning and Analysis Manager to join our team. As a key member of our finance department, you will be responsible for leading the financial planning and analysis function across multiple business units.Key ResponsibilitiesDevelop and manage financial plans and budgets for multiple business...
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Senior Business Intelligence Developer
4 weeks ago
Woburn, Massachusetts, United States Global Channel Management Full timeAbout the JobAt Global Channel Management, we are seeking a highly skilled Senior Business Intelligence Developer to join our team. This role requires a professional with 8+ years of experience in developing and implementing business intelligence solutions.Key Responsibilities Proficient in SQL and PL/SQL for querying and data manipulation. Experienced with...
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Regional Sales Director
1 month ago
Woburn, Massachusetts, United States USI Insurance Services Full timeAbout USI Insurance ServicesUSI Insurance Services is a leading provider of retirement consulting and benefits administration services. With a team of experienced professionals, we offer a range of services including defined benefit actuarial and consulting, defined contribution recordkeeping and consulting, employee communication, health and welfare...
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Woburn, Massachusetts, United States UHS Full timeAbout the RoleArbour Counseling Services is seeking an experienced Assistant Director to join our team in the Partial Hospitalization Program (PHP) in Woburn. As a key member of our leadership team, you will play a vital role in ensuring the high-quality delivery of clinical services to our clients.ResponsibilitiesCoordinate and conduct intakes, assessing...
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Clinical Trainer
4 weeks ago
Woburn, Massachusetts, United States Cytrellis Biosystems Full timeJob DescriptionCytrellis Biosystems seeks a skilled Clinical Trainer to provide customer account clinical training in the assigned territory. The ideal candidate will have a strong clinical skillset and effective communication skills to educate customers on the indicated use of ellacor.Key Responsibilities:Comply with Cytrellis Biosystems quality system...
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Strategic Partnerships Director
1 month ago
Woburn, Massachusetts, United States MedAdvisor Solutions Full timeJob DescriptionAbout the RoleThe Senior Director, Strategic Partnerships at MedAdvisor Solutions will lead the development and execution of the company's partnership strategy, aligning key initiatives with long-term business objectives. This role is responsible for identifying and nurturing high-value relationships with external partners, driving...
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Mechanical Engineering Team Lead
1 month ago
Woburn, Massachusetts, United States EHR Services Full timeJob Title: Manager, Mechanical EngineeringEHR Services is seeking a highly skilled and experienced Manager, Mechanical Engineering to join our Covaris, LLC partnership. This exciting opportunity offers a collaborative individual the chance to work in a fast-paced environment on the development of complex electromechanical instruments, specialized plastic...
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Licensed Practical Nurse
4 weeks ago
Woburn, Massachusetts, United States Maplewood at Weston Full timeJob Title: LPN Wellness NurseLocation: Weston, MAEmployment Type: Part TimeDepartment: Resident ServicesAbout Us:Maplewood Senior Living is a leading operator of premier senior living communities across 6 states, featuring two distinguished brands: Maplewood and Inspire. We are known nationally for innovation in the senior living space, dedicated to...