- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
- DivIHN Integration Inc (North Chicago, IL)
- …metrics related to submissions and approvals. Offers country specific regulatory support Stakeholders: Direct interaction with RA functions including ... reports to a manager or head of a unit/department. Accountability / Scope: As the professional in the Regulatory Affairs function, the individual will assist… more
- DivIHN Integration Inc (Lake Forest, IL)
- …12 Months Description: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department ... May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class...individual contributor, the function of a Regulatory Affairs Specialist is to provide support for… more
- DivIHN Integration Inc (Green Oaks, IL)
- …Main purpose of role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ... but may consider quality assurance, research and development/ support , scientific affairs , operations, or related area. Experience with Regulatory history,… more
- Merck & Co. (Rahway, NJ)
- …needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... areas and externally with-vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.Manages and maintains information and documentation in… more
- Catalent (San Diego, CA)
- …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... QA Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of audit… more
- Signet Health (Taos County, NM)
- …& Alcohol Treatment Program in Taos, NM is actively seeking an experienced nursing professional such as a LPN, Certified Nursing Assistant (CNA) or a Mental Health ... Technician with substance abuse addiction experience for the Recovery Advocate ( RA ) positions. All shifts available - Part-time/PRN - day-evening swing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Vendor Governance is a function within the RA ... and overall success of the vendor partnerships utilized by Regulatory Affairs . Gilead Sciences is seeking an...+ Own initiatives and day to day responsibilities in support of vendor oversight within RA +… more
- Medtronic (Santa Rosa, CA)
- …evident in your applicant profile. + Bachelor's degree. + Minimum of 7 years of direct Regulatory Affairs experience within the medical device industry + Or ... lifecycle. The Prin. RA Specialist will execute regulatory filings to support this strategy such...experience within the medical device industry Desired/Preferred Qualifications + Direct Regulatory Affairs experience supporting… more
- STERIS (Alpharetta, GA)
- Senior Manager, Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Alpharetta, GA, US, 30004 Description: At STERIS, we ... product and service solutions around the globe. Position Summary The mission of the Regulatory Affairs group is to implement effective processes to obtain and… more
- Amgen (Thousand Oaks, CA)
- …affairs experience OR + Bachelor's degree & 12 years of regulatory affairs experience AND + 8 years of direct managerial experience. Previous experience ... science that can turn the tide of serious, life-interrupting illnesses. **Vice President, Regulatory Affairs - Obesity** **Live** **What you will do** Let's do… more
- ThermoFisher Scientific (Wilmington, NC)
- …Strategic Proposal Development, Talent Acquisition, Project Delivery and Bids/Contracts to support the Regulatory Affairs proposal process including ... the **last 3** years **and** in leading and developing professional staff in a regulatory affairs...developing and growing teams within the regulatory affairs space + Ability to strategically support … more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist (Abramson Cancer Center)(Remote Eligible) Job Profile Title ... Regulatory Affairs Specialist Job Description Summary The...and source document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator initiated… more
- ICU Medical (Lake Forest, IL)
- …that facilitate review by regulatory authorities. * Provides daily regulatory support to direct reports in RA , for new product development teams ... Makes independent judgments and decisions based on regulations and professional experience. Ensures alignment with Regulatory Management...industry experience with a minimum of five years in regulatory affairs with direct experience… more
- Medtronic (Northridge, CA)
- …with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD ... 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist, you will develop and...this role is an excellent opportunity for the right regulatory professional to take their career to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory ... , PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation /...professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of… more
- Bausch + Lomb (O'Fallon, MO)
- …of eye health in the future. **Objectives:** Responsible for providing Regulatory Affairs support under direct supervision supporting regulatory ... support facility inspections and participate in other regulatory support activities as required. The position...+ Research engineering standards and medical device regulations. + Support RA Managers in interactions with FDA… more
- Amgen (Thousand Oaks, CA)
- …affairs experience OR + Bachelor's degree & 12 years of regulatory affairs experience AND + 8 years of direct managerial experience. Previous experience ... science that can turn the tide of serious, life-interrupting illnesses. **Head of Regulatory Affairs Policy & Intelligence** **Live** **What you will do** Let's… more
- System One (Deland, FL)
- …responsible for building and maintaining a high-performing regulatory affairs team providing mentorship, coaching, and professional development opportunities ... of 10 years' experience in US Regulatory Affairs within the pharmaceutical or biotechnology industry. Direct...to effectively lead and manage a regulatory affairs team providing mentorship, guidance, and support … more
- Medtronic (Boston, MA)
- …with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. ... SENIOR REGULATORY AFFAIRS SPECIALIST - Digital Technologies...this role is an excellent opportunity for the right regulatory professional to take their career to… more
