- Aequor (Newbury Park, CA)
- …for inclusion in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under under the direction ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical… more
- Merck & Co. (Rahway, NJ)
- …and CRD as needed.Works in partnership with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary… more
- Merck & Co. (Rahway, NJ)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... Business Planning & Strategy. The incumbent works closely with associate directors, directors, VPs, and other senior ...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Robert Half Legal (Des Moines, IA)
- Description We are seeking a Senior Regulatory Affairs Associate based in Des Moines, Iowa. This role will involve overseeing regulatory support and ... * Review, update and draft new Standard Operating Procedures within the Regulatory Affairs Department * Review and prepare outlines of production and special… more
- Allogene (South San Francisco, CA)
- …@AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: The Senior Associate will support all aspects of regulatory affairs related to the ... sciences, or health related field. * Interest in building a career in Regulatory Affairs . * Strong knowledge of eCTD elements and structure including CMC. *… more
- Invenergy (Denver, CO)
- …We own. We operate. We are Invenergy. Job Description Responsibilities + Collaborate with Regulatory Affairs team members in the West region and across regions, ... as well as other internal departments. + Manage external counsel and consultants. + Build relationships with and lobby external stakeholders including those with leadership positions in CAISO, WECC, FERC, state and regional trade organizations,… more
- DLA Piper (Washington, DC)
- …required **Job:** _Lawyer_ **Organization:** _Regulatory & Govt Affairs_ **Title:** _Financial Regulatory Senior Associate or Counsel_ **Location:** ... Together. **Job Description Summary** DLA Piper is seeking a senior -level associate or counsel candidate with 7...and/or a financial institution to work in its Financial Regulatory and Technology Group (FRTG). The FRTG handles cutting… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC...Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying and ... people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory … more
- Astellas Pharma (Northbrook, IL)
- …should be elevated to upper management for further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that ... promotion review processes are compliant with approved company procedures. Represents Regulatory Affairs in cross-functional initiatives such as committees,… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior Leadership. **About you: To be successful in this… more
- Medtronic (Santa Ana, CA)
- Associate Regulatory Affairs Specialist (hybrid) Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There ... medical technology and solutions. Careers That Change Lives The Associate Regulatory Affairs Specialist working...Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for… more
- Stryker (Portage, MI)
- …annually. More information is available at www.stryker.com . We are currently seeking an ** Associate Manager, Regulatory Affairs ** to join our **Acute Care ... to apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -… more
- Novo Nordisk (Princeton, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide ... strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …on labeling and labeling requirements. **Primary Responsibilities:** + Act as Regulatory Affairs authority for specified key products/facilities/equipment with a ... local laws** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 514654 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
