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. Bachelor’s degree with 8...
The 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 r...
Manager, Regulatory Affairs: Base Salary Range $90,000 - $120,000. Perform other regulatory tasks as assigned. Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. ...
Represent Regulatory Affairs on Insmed's Commercial Review Committee providing coordination and meeting facilitation. Minimum of 1 year's relevant work experience in Regulatory Affairs. Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as n...
The Regulatory Manager also develops and implements regulatory strategies to support innovation projects and works in anticipation of regulatory developments with the potential to affect the current portfolio and future pipelines. The Regulatory Manager is responsible for assuring that Nestle Health...
Senior Manager/Associate Director, Regulatory Affairs. Edenbridge Pharmaceuticals is seeking a Senior Manager/Associate Director of Regulatory Affairs to join the Company at its Parsippany, NJ corporate office. Lead and manage a team of Regulatory Affairs professionals. Actively monitor changes in a...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents. The candidate will be leading the regulatory strategies for biologic products ...
Our client is looking to fill the role of CMC Regulatory Affairs. Minimum 5 years of Regulatory Affairs experience in the industry. Provide regulatory assessments of CMC change controls. Regulatory support for state and FDA inspections. ...
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, regu...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents. The candidate will be leading the regulatory strategies for biologic products ...
The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Sr Manager Clinical Affairs in the development & execution of the regulatory strategy. As...
Managers, Regulatory Affairs (Parsippany, NJ) to evaluate change controls, provide regulatory assessment within the company system to regulatory documents, and formulate strategies with minimal guidance, to ensure proper filing categories. Requires a Bachelor’s degree in Pharmacy Administration, Pha...
The Regulatory Manager also develops and implements regulatory strategies to support innovation projects and works in anticipation of regulatory developments with the potential to affect the current portfolio and future pipelines. The Regulatory Manager is responsible for assuring that Nestlé Health...
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...
We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
The Regulatory Affairs Manager will be responsible for independently compiling and maintaining compliant US drug product applications throughout product lifecycle i. The Regulatory Affairs Manager is a self-motivated, detail-oriented, flexible team player who is able to multi-task, and work independ...
Regulatory Affairs Manager - Permanent - Bridgewater, NJ. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introducti...
Represent Regulatory Affairs on Insmed’s Commercial Review Committee providing coordination and meeting facilitation. Minimum of 1 year’s relevant work experience in Regulatory Affairs. Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as n...
The Regulatory Affairs Project Manager is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; Working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory ...
Support the development of regulatory strategy and update strategy based upon regulatory changes. Manage the regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities. Ensure timely completion, accuracy, and quality of all regulatory and submiss...
The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Sr Manager Clinical Affairs in the development & execution of the regulatory strategy. As...
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 requi...
Our client is looking to fill the role of CMC Regulatory Affairs. Minimum 5 years of Regulatory Affairs experience in the industry. Provide regulatory assessments of CMC change controls. Regulatory support for state and FDA inspections. ...
Regulatory Affairs Senior Manager is responsible for leading the regulatory strategy and managing the regulatory compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs. Lead and enhance the regulatory program to enable the business wit...
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, regu...