- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC ... higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
- Eisai, Inc (Fort Wayne, IN)
- …hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in ... that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(EGP), in collaboration with Senior Medical Director Serve as NNI Medical Affairs representative on Medical & Science Team Review and provide comments to ... instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their ... Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for commercial,… more
- Merck & Co. (Rahway, NJ)
- …for approval to Strategic Policy & Sustainability Council.Serve as the GPP representative in senior -level cross-functional working groups and leadership teams ... localization, AI, go to market approaches, and build internal relationships with senior SMEs in Research and Development, Manufacturing, and Human Health in order… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...approve deliverables of the safety surveillance team Is safety representative in Trial Squad Plan, execute and drive all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... brand/therapy area strategy and key decisions. US brand/therapy area representative across various NNI governance committees Omnichannel Experience Strategy: Provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical...members. He/she will also serve as the Clinical Science representative or delegate at key R&D forums/groups such as… more
- Catalent Pharma Solutions (Bloomington, IN)
- ** Senior Regulatory Affairs Representative ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... and cold storage. Catalent Pharma Solutions in Bloomington, IN is hiring Regulatory Affairs Senior Representative who is accountable for direct… more
- Medtronic (Minneapolis, MN)
- …Regulatory department and other business functions. This position reports to the Senior Regulatory Affairs Manager. **Role And** **Responsibilities:** + ... MN but a remote worksite may be considered. The ** Senior ** **Principal Regulatory Affairs ** will...within the Responsibilities section of this job description are representative of those that must be met by an… more
- Abbott (Sylmar, CA)
- …Our location in Sylmar, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Specialist** with our Cardiac Rhythm Management ... reviews and approves change orders. + Acts as a regulatory representative on core product development teams,...attention to detail. **Preferred** **Qualifications** + Master's Degree in Regulatory Affairs and may be used in… more
- Kelly Services (Redondo Beach, CA)
- **Title** : Regulatory Affairs Specialist ( Senior Level) **Pay** : $38-$50/hr depending on experience **Shift** : M-F, standard working hours. **Hybrid** ... role **Temp to hire** **Overview:** We are seeking a Regulatory Affairs Specialist ( Senior Level)...Strategy Across All Functional Areas + Serve as a Regulatory Representative to Marketing, Clinical, Research Teams,… more
- Bausch + Lomb (Columbus, OH)
- …other company functions during Regulatory Authority inspections. + Serve as Regulatory Affairs representative on facility/site Local Change Management ... cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain as appropriate in a timely… more
- Integra LifeSciences (Harrisburg, PA)
- …with the Company's Notified Bodies and regulatory inquiries regarding regulatory issues/questions. + Maintains Regulatory Affairs product files ... and/or ability required for this position. + Bachelor's degree in science, Engineering, Regulatory Affairs , or other technically related field. + Minimum of 8… more
- Medtronic (Minneapolis, MN)
- …safely and efficiently, with more predictable procedure times and outcomes. The ** Senior Regulatory Affairs Specialist** develops strategies for worldwide ... Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance...within the Responsibilities section of this job description are representative of those that must be met by an… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist** to join our team on-site in ... applications to achieve departmental and organizational objectives. + Acts as a regulatory representative on core product development teams, communicates … more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing...compliance and product expansion. + Acts as the company representative with regulatory authorities + Prepares and/or… more
- J&J Family of Companies (Irvine, CA)
- Senior Director, Scientific Affairs for Aesthetics and Reconstruction - 2406214927W **Description** Johnson & Johnson is currently seeking a ** Senior ... potential. At Johnson & Johnson, we all belong. The Senior Director, Scientific Affairs for Aesthetics and...plans to meet business needs. + Acts as a senior company representative interacting with external scientific… more
- BeiGene (Emeryville, CA)
- **General Description:** + The Senior Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to ... **Essential Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides...Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics… more
