- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies for ... and externally, occasionally with senior management. + Advises local teams on regulatory requirements. Interprets and ensures compliance with applicable Health… more
- Takeda Pharmaceuticals (Lexington, MA)
- …least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products ... best of my knowledge. **Job Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve as an… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...highly motivated, and experienced individual for the position of Manager , CTSA. The CTSA Associate Manager is… more
- Dana-Farber Cancer Institute (Boston, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** Regulatory Compliance ** + Prepares and submits all protocol… more
- Teledyne (Billerica, MA)
- …**_Elkridge, MD_** **_Thousand Oaks, CA_** **_Billerica, MA_** **Job Summary:** The Licensing Manager , Trade Compliance works with a team of licensing analysts ... research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an… more
- Cardinal Health (Mansfield, MA)
- …and manages resources for General Operations for E&L, EO Residuals, and pharmaceutical testing programs to assure technical conduct, regulatory quality, and ... development of SOPs, guidance, protocols, reports supporting laboratory GMP/GLP function in compliance with FDA, ICH, and other regulatory guidance. + Support… more
- Bristol Myers Squibb (Devens, MA)
- …with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and ... tasks, often using creative problem-solving. + Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of **Sr. Manager , Medicaid Contract Administration.** The Sr. Manager ,… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Nanobiosym, Inc. (Cambridge, MA)
- …knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance . Qualifications Qualifications * Minimum 8 years' ... and requirements are below. The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the Nanobiosym… more
- Dana-Farber Cancer Institute (Boston, MA)
- …study group registrar and pharmaceutical company as outlined in protocol. ** REGULATORY & COMPLIANCE ** + Assists in the responsibility for essential document ... This Assistant Clinical Research Manager (ACRM) position will work within the clinical...their disease group's clinical trial portfolio and all related regulatory and compliance requirements. + The ACRM… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of Sr. Manager , Revenue Accounting. The individual will play a key… more
- Lundbeck (MA)
- … Environment/ Compliance ** - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... Psychiatry Account Manager - Cape Cod, MA Requisition ID: 5685...and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. **REQUIRED EDUCATION, EXPERIENCE and SKILLS:**… more
- Eurofins (Norwood, MA)
- …seminars and training sessions, focusing on topics such as product safety, and regulatory compliance , to educate and empower clients and colleagues. + Actively ... and a commitment to fostering client relationships through technical excellence and compliance expertise. Key Responsibilities: + The Technical Manager will be… more
- Eurofins (Norwood, MA)
- …seminars and training sessions, focusing on topics such as product safety, and regulatory compliance , to educate and empower clients and colleagues. + Actively ... and a commitment to fostering client relationships through technical excellence and compliance expertise. Key Responsibilities: + The Technical Manager will be… more
- AbbVie (Waltham, MA)
- …R&D, or Industry-related experience. + Preferred Experience: 2-3 years in pharmaceutical regulatory activities + Demonstrates excellent negotiation skills, ... products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of **Senior Manager , Financial Planning & Analysis (FP&A),** supporting our R&D… more
- J&J Family of Companies (Boston, MA)
- …program management experience, experience in program/project management of quality and compliance activities associated with pharmaceutical labeling is preferred ... Manager , Global Labeling Operations - 2406213366W **Description** Johnson...in audits and inspections and in support of other compliance deliverables + Maintain oversight of Global Labeling vendors… more
- Takeda Pharmaceuticals (Boston, MA)
- …protocols. You will provide expert guidance, makes critical approvals, and ensures compliance with regulatory requirements. As a Subject Matter Expert (SME), ... to the best of my knowledge. **Job Description** **Job Title** : Senior Manager , Validation, Cell Therapy Quality **Location** : Cambridge, MA **About the role:**… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of **Senior Manager , Financial Planning & Analysis,** supporting our Technology and… more