The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.

Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.

This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.

Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development. Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.

The Sr. Medicare Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations Medicare Advantage line of business. The Sr. Medicare Compliance Program Manager will be a member of the Medicare Advantage cross-functional project team and their role will be to ensure compliance, help to identify and mitigate risks of noncompliance and provide regulatory requirements and guidance on how to implement, operationalize and optimize.

As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.

Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.

Environmental Permitting: Assist clients in navigating the regulatory permitting process, including obtaining permits for activities such as air emissions, wastewater discharge, wetland impact, and hazardous waste management.

Preferred Qualifications: Knowledge of: Support services network, including programs and services offered by the Executive Office of Elder Affairs, Massachusetts Rehabilitation Commission, Department of Mental Health, Department of Developmental Services, MassHealth, Home and Community Based Waiver programs, and other Health and Human Service organizations.

In collaboration with Academic Affairs, responsible for understanding and assessing teaching and learning needs; and making recommendations on how the learning management system can be used to support those needs.

Familiarity with the environmental considerations, permitting processes, and regulatory requirements specific to offshore wind developments. Regulatory Compliance: Stay up-to-date with federal, state, and local environmental regulations and ensure that consulting projects adhere to all applicable laws and guidelines.

In collaboration with the Associate Chief Nurse, the Nursing Director plans, organizes, implements and oversees clinical and program development in the assigned area(s) to contribute to meeting the mission and goals of Brigham & Women’s Faulkner Hospital as well as the regulatory requirements of the JCAHO and other applicable federal, state and local regulatory or accrediting agencies.

Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP and behavioral health, as well as the associated and relevant federal, state and local regulatory entities.

Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.

In this collaborative role, you will be responsible for the research and development of AML procedures, regulatory engagement, and issue management related to our AML/KYC program, making a significant impact as our business continues to grow.