Manage regulatory authorizations and product registrations for the Human Nutrition and Health and Performance Gases, with the support of Corporate Regulatory Affairs teammates and contractors. Provide expert guidance to internal stakeholders on regulatory affairs as they relate to Balchem' s product...
Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings. Work closely...
To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. Assist with Regulatory Database and Systems maintenance including but not limited to:. Coordinate, prepare and review regulatory documents/c...
Associate Director/Director, Regulatory Affairs (Oncology). This role will be reporting into the VP of Regulatory Affairs and will be serving as the Lead for a US Phase III Oncology program. Serve as SME for US Regulatory Affairs in cross-functional groups. They are looking for an Associate Director...
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...
Support the Regulatory Affairs Therapeutic Area Head for IN&F in this strategic leadership position responsible for leading and developing the global regulatory strategies, overseeing health authority interactions and for providing oversight for the preparation, review and evaluation of submission d...
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...
Executive Director Regulatory Affairs - Companion Diagnostics amp Precision Medicine. Significant experience in regulatory affairs and diagnostic related development (e. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leaders...
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...
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...
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...
As a Regulatory Affairs Specialist, your role will be to coordinate, prepare, and review regulatory documents/certifications required for both domestic and international projects. Job Title: Regulatory Affairs Specialist. Flavor industry within Regulatory Affairs. Your role will also involve support...
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/...
Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. Assists in th...
Manage regulatory authorizations and product registrations for the Human Nutrition and Health and Performance Gases, with the support of Corporate Regulatory Affairs teammates and contractors. Provide expert guidance to internal stakeholders on regulatory affairs as they relate to Balchem’ s product...
Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities. New Quality Assurance Regulatory Affairs Opportunity!. We are seeking Quality Assurance & Regulatory Affairs Manager to join our dynamic team. The successful candidat...
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...
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 ...
Administer regulatory change program review of vendor tools/applications available for regulatory change monitoring oversee selection/implementation/administration of vendor tool/application if warranted summarize and distribute new/amended rule proposals and rules to internal constituents oversee i...
Eligibilities & qualifications....
Job Title: Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be instrumental in CRM cleanup and data migration tasks. ...
Regulatory Strategy Development: Lead the development and implementation of regulatory strategies aligning with business priorities and regulatory standards. Regulatory Compliance/Intelligence Oversight: Monitor regulatory developments and stay abreast of industry best practices in the animal health...
Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers’ regulatory submissions. Acts as a RA Core team Member (RA CTM) and works with RA Manager and Platform Leaders to ensure ti...
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 ...
Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities. We are seeking a highly motivated and experienced Quality Assurance & Regulatory Affairs Manager to join our dynamic team. The successful candidate will be responsibl...