- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... relationships with other personnel in Regulatory Affairs , CMR, and other local and...meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team… more
- 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 ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... and industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and… more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an ... the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific,… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm ... Management team in Sylmar CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, … more
- Abbott (Alameda, CA)
- …healthcare. As an individual contributor, the Quality Assurance and Regulatory Affairs (QARA) Project Manager combines knowledge of business objectives, ... quality system process, and regulatory compliance matters to drive improvement initiatives. The individual...projects in a regulated industry, leading cross-functional and/or cross-divisional project teams * Prior experience in the development and… more
- Abbott (Abbott Park, IL)
- …and scientists. **The Opportunity** Our location at Abbott Park, IL is looking for a Regulatory Affairs Project Manager onsite within the Abbott Quality ... site registration and device listing activities along and contribute to regulatory metrics. The individual will exercise judgement within generally defined practices… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... their assigned projects. This role is responsible for linking regulatory affairs information to internal and external...to drive Target Product Profile objectives. + Provides consistent regulatory advice to project teams regarding the… more
- Abbott (Santa Clara, CA)
- …in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within ... Senior Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge… more
- Abbott (Sylmar, CA)
- …fingersticks. Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management ... The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge… more
- Hologic (Marlborough, MA)
- …based out of our San Diego or Marlborough campus, and are looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities ... Manager , Regulatory Affairs (IVD... Manager , Regulatory Affairs (IVD On-Market/Sustaining) San Diego,...vitro diagnostic systems, including software and hardware; to meet project timelines and / or regulatory obligations.… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...and compliance to establish a compliant culture. + Represent Regulatory Affairs on cross-functional project … more
- Abbott (Plymouth, MN)
- …people to restore their health and get on with their lives. **The Opportunity** The Regulatory Affairs Manager will work on-site at our Plymouth, MN location ... As a manager , the function of a Manager Regulatory Affairs is to...across organizational units. May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts… more
- Invenergy (Denver, CO)
- …be before or after the 3-day posting window. Job Description Position Overview The Manager /Senior Manager , Regulatory Affairs will represent Invenergy ... expansion. + Assist in data collection for market registration, project participation in relevant markets. + Prepare annual budgets...+ Excellent verbal and written communication skills. Base Pay Manager , Regulatory Affairs : 125,000.00 -… more
- Philips (Murrysville, PA)
- The Regulatory Affairs Program Manager ...and a minimum of 3+ years' experience successfully leading Regulatory Affairs program/ project teams in ... accurate and timely tracking of regulatory activities and ensures validation of regulatory affairs software tools. **You're the right fit if:** + You've… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** The US Licensing Manager , Regulatory Affairs , will lead a licensing team and manage the completion of various regulatory work ... projects. **Job Description** **Essential Responsibilities:** As the US Licensing Manager , Regulatory Affairs , you will:...10+ licensing engineers and contractors direct reports to support project delivery on time with quality + Manage US… more
- Fortive Corporation (CA)
- The Medical & Scientific Affairs Project & Operations Manager will work under the supervision of the Chief Medical & Scientific Officer (CMO). This role ... and guidelines, this position: + The Medical & Scientific Affairs (MA) Project & Operations manager...response letters, etc. + Collaborate with various departments, including regulatory affairs , QA and product SMEs to… more
- Entergy (Austin, TX)
- …Exempt employees may not be paid overtime associated with such duties. **Job Segment:** Regulatory Affairs , Compliance, Law, Marketing Manager , Manager , ... responses. Maintain compliance with case procedural schedules. + Formulate or implement regulatory affairs policies and procedures to ensure that regulatory… more
- Herbalife (Torrance, CA)
- Manager , Regulatory Affairs Category: Global Public Affairs Position Type: Regular Full-Time External ID: 16707 Location: Torrance, CA, United States ... share to linkedin Apply Now **Overview** THE ROLE: The Manager , Global Regulatory Affairs &...and collaborate with other departments. * Ability to integrate project work of team with strategic undertakings; willingness to… more
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