The Director, Regulatory Affairs should have an advanced degree, preferably in the sciences, and have demonstrated application of regulatory expertise by at least 8+ years pharmaceutical industry experience. A long term consulting client of X4 Life Sciences is looking to add a Regulatory Affairs Sub...
Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to the marketplace? This is the role for you!. My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic API...
Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. Launch the company's regulatory strategy having leadership over all regulatory activities. This role will lead the North America regulatory strategy and work extremely clos...
Regulatory Affairs (2) Regulatory Affairs (4). Responsible for day-to-day Quality and Regulatory Operations for the company including the development and maintenance of a Quality Management System (QMS) supporting business operations and assuring compliance with existing and new...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
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 ...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies Responsible as a contact parson with regulatory authorities (MHLW and PMDA, etc. Develop an efficient and high value-added Japan regulatory development strategy in line with global strategi...
The Senior Director, Regulatory Affairs - Clinical (Early Development), may be called upon to guide a team of Clinical Regulatory Affairs professionals providing strategic regulatory guidance to cross-functional project teams and responsible for product development and post marketing commitments. Th...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
Specialist for Regulatory Affair s is responsible for regulatory activities including submission, operational and compliance for US-licensed products and additional project/s assigned. Responsibilities include:As the US Product Owner (USPO), responsible for the maintenance of the US dossiers and the...
Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Dem...
Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits ...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities. We are seeking Quality Assurance & Regulatory Affairs Manager to join our dynamic team. The successful candidate will be responsible for overseeing all aspects of qua...
Job Title: Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be instrumental in CRM cleanup and data migration tasks. ...
Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Review protocols and...
Eligibilities & qualifications....
You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interacts with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluates proposed device changes. Here are 10 reasons to join our Regulatory Affairs/...
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 ...
Job Title: CMC Regulatory affairs / Animal Health Care. Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications. Lead develop...
Our client is currently seeking a Senior Manager, Regulatory Affairs. Represent regulatory affairs on project teams and support R&D and clinical research activities. Regulatory Affairs Certified is a plus. Develop and implement global regulatory strategies for investigational and marketed pharmaceut...
As the Senior Manager, Regulatory Affairs you will be responsible for the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area (“TA”). Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Lead ...
Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency, a...