They are seeking a dynamic Director of Regulatory Strategy to steer our groundbreaking projects through the complex regulatory landscape with vision and precision. Bachelor's degree in a relevant life sciences field with at least 8 years of experience in the biopharmaceutical industry, particularly ...
Senior Director Regulatory Affairs - Confidential. Senior Director Regulatory Affairs. Due to an accelerated growth trajectory, the client is looking for a Senior Director Regulatory Affairs who as a member of the leadership team will help make decisions that are critical at this time. This leader w...
Provide overall company leadership and direction for worldwide Tecomet Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. ...
Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies. Collaborate cross-functionally with internal teams, including clinical, clinical operations, quality assurance, pharmacovigilance, and non-clinical, to ...
Senior Manager of Regulatory Affairs and Quality Assurance - (Medical Device) - Hybrid in MA. Our client is a growing boutique IVD and Medical Device company and they are seeking a Senior Manager of Regulatory Affairs and Quality Assurance to lead a small international team to ensure compliance with...
Participate as a regulatory representative in relevant teams, advising on regulatory strategies, submission preparation timelines, processes, and requirements. Monitor and evaluate the US regulatory affairs environment to maintain awareness of current and future risks that may impact the business. C...
Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. Can apply and adapt this understanding to projects to enhance probability of regula...
Are you a seasoned regulatory CMC leader looking for a new challenge? We are seeking a dynamic professional to lead a Global Regulatory Affairs CMC team in a top-tier biopharmaceutical company. This is a pivotal role that will shape global CMC regulatory strategies through all phases of product deve...
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, inc...
The role involves leading strategic and operational aspects of Regulatory Affairs and Quality Assurance for clinical studies and product approvals. Regulatory Affairs and Quality Assurance, with 10+ years in leadership roles. Develop and guide regulatory strategies, risk assessments, and critical is...
Must have previous experience in conducting all regulatory affairs activities including meeting submissions, IND, and clinical trial applications and regulatory filings. Requires experience in the management of regulatory documentation and compliance, and in the management of a regulatory functional...
Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on reg...
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties. Significant regulatory affairs experience is required. Provides stra...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings. Our premier client is currently seeking an Executive Director/Vice President...
Leads the Regulatory Affairs team to design and execute regulatory strategy for approval and commercialization of the company’s products, including preparation, review, and submission of appropriate background documents and regulatory submissions. Keeps executive leadership team informed of regulato...
Pharmacist in Boston, Massachusetts, 02114!. JOB DESCRIPTION - PHARMACIST (GT). The pharmacist accurately fills and dispenses prescription and nonprescription drugs to customers; compounds medications; provides drug information to customers, health practitioners, and the general public, reviews drug...
Our client seeks a full-time Ambulatory Care Pharmacist for a community near the coast in Massachusetts! This is a Health Center role providing clinical duties with a strong emphasis on direct patient care. At a minimum, all applicants must have a PGY1 Residency; they will consider pharmacists compl...
Our hospital is seeking an experienced Inpatient Pharmacist to work in one of Massachusetts' most luxurious areas. All applicants must have, at minimum, a Bachelor's in Pharmacy & at least 2 years of recent hospital pharmacist experience or PGY1 Residency training. Clinical Staff Inpatient Pharm...
Pharmacists are responsible for oversight of daily compounding activities in the cleanroom with direct oversight of compounding technicians. Active Pharmacist License in home state (AR and CT). The Pharmacist is often completely gowned up in an aseptic clean room extended periods of time. ...
The Loan Compliance Analyst will provide guidance on applicable local, state, and federal regulations. Thorough review of Compliance matters will identify trends and errors and oversee remedial training. Partnership with the Production and Servicing teams to provide guidance on all compliance matter...
Proven experience as a Program Manager, specifically in M&A or data migration projects within the life sciences or pharmaceutical industries. ...
Pharmacists are responsible for oversight of daily compounding activities in the cleanroom with direct oversight of compounding technicians. Active Pharmacist License in home state (AR and CT). The Pharmacist is often completely gowned up in an aseptic clean room extended periods of time. ...
Case Manager for the Agency with Choice/Alternative Day Program . The Agency with Choice/Alternative Day Program is seeking to add a key team member to partner with families and consumers. The goal of this partnership is to create and implement innovative and individualized day progr...
Reviews identified issues to be pursued based on large, unusual or questionable items that produce a significant tax or compliance effect and utilizes the tax law and facts needed to resolve them. ...