Manager, Regulatory Affairs & Quality Assurance Salary at Vlv Associates Inc BETA

Location: Florham Park, NJ - Onsite 50% (2-3 days per week) Duration: 1 Year Overview The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional regulatory authorities. While providing valuable support to higher-level management, the Senior Manager focuses on executing regulatory tasks, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for our QOL initiatives. Responsibilities Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regula

About the Company VIZOR is a material coating technology company with offices in NYC and NJ. The company has created a suite of active ingredients and specialty raw materials that go into various consumer goods. The team is comprised of some of the leading technical minds in personal care with over 50 years of combined experience in the industry. We are seeking an experienced an Assistant Manager to lead our quality management and regulatory compliance efforts in our OTC and personal care manufacturing operations. Personal Care experience is required for this opportunity. Key Responsibilities Quality Management System (QMS) Development: Design and implement a comprehensive QMS that integrates quality assurance, quality control, and compliance processes throughout the company. Regulatory Compliance: Ensure adherence to FDA, EPA, ISO, and other relevant national and international standards, with particular focus on solid oral dosage forms and personal care products. Raw Material Qualific

The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. In this role, a typical day might include: * Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure * Assisting in coordination and preparation for Agency meetings and associated briefing document preparation * Managing and tracking queries and commitments with regulatory agencies, collaborates with subject matter experts to provide w

Summary: The Compliance Regulatory and Assurance (CPL RA) team is a recently established “Center of Excellence” within the CACIB Compliance Function reporting directly to the Chief Compliance Officer (CCO). The CPL RA team provides strategic and centralized management of the supervisory activities of the Firm’s regulators and related developments, focusing on regulatory reviews and examinations and continuous monitoring activities. CPL RA serves as the central point of contact with key supervisory regulators globally to facilitate open, cooperative and constructive relationships; provides advice and guidance on regulatory interactions and engagement; oversees responses to and commitments made to regulators; and apprises Senior Management and relevant governance bodies and stakeholders of these matters and related significant regulatory developments. The CPL RA team is comprised of four coverage areas: Project Management, Regulatory Coordination, Regulatory Watch, and Assurance. This Pr

Lincoln Medical and Mental Health Center is one of New York City's premier acute care hospitals. Located in Downtown Bronx, Lincoln is a teaching hospital renowned for its Centers of Excellence, and a recognized industry leader in the implementation of state-of-the art medical technology and best practices. Our team of highly trained and caring medical professionals is dedicated to providing the highest quality health care that is safe, compassionate, culturally competent and patient-centered. Comprehensive services are offered in three major primary care areas: Medicine, Pediatrics, and Women's Health in addition to more than eighty (80) specialty services.At Lincoln, the safety and comfort of our patients is our number one priority. At NYC Health + Hospitals, our mission is to deliver high quality care health services, without exception. Every employee takes a person-centered approach that exemplifies the ICARE values (Integrity, Compassion, Accountability, Respect, and Excellence) t

Company Description: Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions: Named Sciences Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team

Part of the Interparfums group founded in 1982, Interparfums USA develops, manufactures and distributes prestige perfumes and cosmetics as the exclusive worldwide licensee for Abercrombie & Fitch, Anna Sui, DKNY, Donna Karan, Dunhill, Graff, GUESS, Hollister, MCM, Oscar de la Renta, Roberto Cavalli, Salvatore Ferragamo and Ungaro. Through its global distribution network, the Company’s products are sold in over 120 countries. The Global Regulatory Affairs Manager will lead the team tasked with supporting product submissions globally. You will play a key role in overall product compliance as it applies to domestic and international markets. The ideal candidate must have the ability to stay knowledgeable & current with industry regulations and how to integrate them into the current business model. You will coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met. This position is based in office from Mondays-Thursdays, and remote on Fridays.

Job Description Job Description · Prepare and review various modules of ANDAs, NDAs, and responses to FDA queries. · Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for NDA’s. · In-depth knowledge and experience of regulatory CMC documents review, and approval is required. · Provide regulatory guidance to cross functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms. · Stay current and proactively implement new regulations published by the US FDA · Establish and maintain effective internal and cross-functional team communications i.e. provide regular feedback and communicate work challenges/issues and successes. · Maintenance of Electronic Submissions Gateway account and eCTD software · eCTD compilation experience is preferred. · Any other work assigned by the supervisor. Requirements and Qualifications: · Bachelor’s degree with 8 plus years’ experience in