Trabajos regulatory en Teaneck, New Jersey (NJ) State

You will support all regulatory-related activities, including but not limited to: researching industry updates pertaining to labeling compliance; supporting the review processes for packaging, marketing materials, and digital information. Research and consult on food labels, packaging, and other ...

Plan and Execute Regulatory Transformation project with excellent presentation skills, ability to manage situations and team structure incl. Identify, plan and execute automation and transformation approach in the Regulatory. ...

Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications. Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance. Deliver all re...

COMPLIANCE/REGULATORY PROFESSIONAL. ...

Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements. Ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging. Work closely with...

Also ensure that additional regulatory practices are in line with local, state, and federal laws. Point of internal contact for customer inquiries regarding product regulatory compliance matters. Be prepared to assist customers and the Emergency Response team by maintaining and providing technica...

Launch the company's regulatory strategy having leadership over all regulatory activities. Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. This role will lead the North America regulatory strategy and work extremely c...

You'll be responsible for creating and implementing regulatory strategies, directing and implementing the preparation of US Regulatory submissions, meeting deadlines for regulatory agencies, shortening the review process, and receiving successful approval of pharmaceutical applications. Meet's pa...

Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements. Ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging. Work closely with...

Also ensure that additional regulatory practices are in line with local, state, and federal laws. Point of internal contact for customer inquiries regarding product regulatory compliance matters. Be prepared to assist customers and the Emergency Response team by maintaining and providing technica...

Our client, a Reputable, Global Pharmaceutical Company, is seeking a Regulatory Affairs Strategy professional at the Director level. This role will advise, develop and implement regulatory strategies for specific assets within Oncology. The position will report directly into the VP of Regulatory ...

The Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of labeling content along with t...

Launch the company's regulatory strategy having leadership over all regulatory activities. Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. This role will lead the North America regulatory strategy and work extremely c...

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 strat...

The Director of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant on the Regulatory Operations Leadership Team. Director, Head of Global Dossier Planning – Regulatory Operations page is loaded. Director, Head of Global Dossier Planning – Regulatory ...

They are looking for a Director of Regulatory Compliance Audit to join their team. In this role, the Director of Regulatory Compliance Audit manages the completion of the annual Internal Audit Plan by independently planning and conducting internal audits from start to finish; assigning, reviewing...

Manager, Regulatory Strategy page is loaded. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for mes...

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 reg...

The Director will be involved in a broad range of activities to support obtaining needed regulatory approvals and sustaining compliance for enterprise programs and services including: conducting internal and external research for regulatory standards and interpretations to assist in program desig...

As the Senior Project Engineer- Hydrology and Regulatory Compliance, you will be responsible for the design of stormwater management, open channel projects, hydrologic/ hydraulic modeling, and preparation of regulatory permit applications. Senior Project Engineer- Hydrology and Regulatory Complia...

As the US Product Owner (USPO), responsible for the maintenance of the US dossiers and the execution of lifecycle and regulatory compliance activities of the assigned licensed products in line with business targets and regulatory commitments. Maintain regulatory database including submission, aut...

AVP, Product and Regulatory Counsel page is loaded. AVP, Product and Regulatory Counsel. AVP – Product and Regulatory Counsel. VP – Product and Regulatory Counsel. ...

The responsibilities include providing global regulatory leadership and direction for Rocket’s gene therapy products, including developing long and short-term planning of regulatory projects that align with the company's business plan, and developing strategies to ensure effective achievement of ...

Senior Corporate Counsel – Digital and Technology, Regulatory Law. In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regu...