- Philips (Orlando, FL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs -...as a result of an agency referral where no pre -existing agreement is in place. Where agency agreements are in ... people to make a difference with. **How you'll spend your day** As Manager , CMC Regulatory Affairs you will be responsible for managing the day-to-day… more
- Philips (Orlando, FL)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...requirements are determined to go into effect._ + _Providing regulatory support for ( pre -) clinical studies, including… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...pre -BLA) for review by Project Leaders + Write Regulatory documents translating team strategy into regulatory … more
- GE Vernova (Wilmington, NC)
- …working groups. Occasional travel is required. The role is in Regulatory Affairs and reports to the General Manager of Nuclear Programs. **Job Description** ... **Job Description Summary** The New Plant/Product (NPP) Licensing Manager will establish the vision & strategy and...establish the vision & strategy and drive execution for Regulatory Affairs to accelerate the licensing needed… more
- Medtronic (Boston, MA)
- Principal Regulatory Affairs Specialist - Surgical The Principal Regulatory Affairs Specialist will play a key role in launching new products and ... US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the ... US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, ...interactions with US FDA, OPDP and Health Canada for regulatory related activities by drafting pre -meeting briefing… more
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager , Regulatory Affairs ... regulatory agencies through oral and written communications regarding pre -submissions strategies, potential regulatory pathways, compliance test requirements,… more
- Bausch Health (Bothell, WA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations ... related field. + Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience of independently authoring complete… more
- Edgewell Personal Care Brands, LLC (CT)
- …work instructions and standard operating procedures. Assists with the training of regulatory affairs personnel and provides direction on specific projects. ... responsibility for one or more colleagues. **Accountabilities** + Design and implement Regulatory Affairs strategies, policies and objectives in accordance with… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager Regulatory Affairs Strategic Labeling, develops and maintains ... and coordinates review and approval of these documents with changing regulatory environments. Leads discussions to ensure global consistency of labeling. Educates… more
- Teva Pharmaceuticals (West Chester, PA)
- …(Dir, Sr Manager , Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated ... Senior Director Regulatory Affairs CMC (Biologic Products) Date:...requirements ⦁ Experience with biologic combination products (auto injectors, pre -filled syringes, wearable sensors, etc) ⦁ Knowledgeable in drug… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager ** position is an onsite ... regulatory strategy and update strategy based upon regulatory changes + Support pre and post approval clinical strategy and submission activities +… more
- AbbVie (South San Francisco, CA)
- …internal cross-functional team who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, & ... and LinkedIn. Job Description Key Responsibilities + Responsible for providing regulatory strategy & support for global development. + Responsible for supporting… more
- Medtronic (Northridge, CA)
- …employees in more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist, you will develop and implement medical device ... from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions...level. All significant issues will be reviewed with the manager . + Maintain proficiency in global regulatory … more
- Novo Nordisk (Princeton, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- BeiGene (Emeryville, CA)
- …and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre -meeting packages, and interactions with Heath Authorities as ... **General** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at the ... project level in developing and executing regulatory strategy and compliance plans to promote and support...Core team Member (RA CTM) and works with RA Manager and Platform Leaders to ensure timely execution of… more
- Teleflex (Philadelphia, PA)
- Clinical Affairs Manager - Vascular **Date:** May 16, 2024 **Location:** Philedelphia, PA, US **Company:** Teleflex **Expected Travel** : Up to 50% **Requisition ... that make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides clinical expertise, insight and support to clinical… more
- Abbott (Princeton, NJ)
- …collaborative study protocol versions with APOC and Principal Investigator(s). The Scientific Affairs Manager will also liaise with cross-functional team members ... provide product training, study design, protocol and/or workflow development. The Scientific Affairs Manager will also support abstract, poster and manuscript… more