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...
Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs. Responsible for leadin...
The Associate 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...
Manager Global Regulatory Affairs. Must have Global Regulatory Affairs experience in the pharmaceutical or biotechnology industry. A minimum of 5 plus years Regulatory Affairs experience. Must have Global Regulatory Affairs experience in the pharmaceutical or biotechnology industry. ...
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...
Job Title: Lead Regulatory Affairs. 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 associ...
As the Senior Vice President/Head of Regulatory Affairs, you will play a pivotal role in shaping the regulatory strategy and ensuring compliance for their portfolio of ophthalmic products. Oversee the preparation, submission, and management of regulatory submissions, including INDs, NDAs, BLAs, and ...
Regulatory Affairs Specialist requires:. Regulatory Affairs Specialist duties:. Ensure continuing familiarity with all of the latest applicable regulatory and toxicological information. ...
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...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
Director Regulatory Affairs and Value Added Services. Establish links with relevant regulatory authorities toreceive regulatory updates on new and proposed legislation that may impact thebusiness. Tolead and manage the strategic and operational performance of the Quality,Regulatory and Documentation...
Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with project associate on compilation of information and supportive documentation for FDA briefing packages Work with project leader and team to draft FDA meeting requests and sup...
Train and obtain access on company tools and systems that support contracting, PO, and invoicing for regulatory affairs in the US and EMEA. In this role you’ll be working with cross-functional teams to assist with the coordination and completion of international regulatory documents. This role will ...
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...
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...
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...
Im Regulatory Affairs, Advertising, Director, Regulatory, Associate, Business Partner, Manufacturing, Business Services. Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. ...
Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of prop...
Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...
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 development and execution of global product and project regulat...
Regulatory Affairs Labeling Associate Level – I is needed to support Client' business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Applying strategic thinking, pharmaceutical educational knowle...
The Senior Regulatory Affairs Associate/Manager plays a key role in ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-soluble products) while also providing ...
Essential Functions Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape Assess risk and advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and...
The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. T...
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...