- Jazz Pharmaceuticals (Philadelphia, PA)
- …new ways to solve problems.Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and ... apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives… more
- CSL Behring (King Of Prussia, PA)
- …serious and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our King of ... will contribute to the vision, goals and improvement of Global Regulatory Affairs and includes...to enable a and planning to future our requirements. Lead regulatory strategies and activities globally -… more
- Teva Pharmaceuticals (West Chester, PA)
- …biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure ... will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in...applications and product life cycle management submissions with the Global Regulatory Affairs Team from… more
- Teva Pharmaceuticals (West Chester, PA)
- …difference, and new people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help ... Senior Director Regulatory Affairs CMC (Biologic Products) Date:...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- Teva Pharmaceuticals (West Chester, PA)
- …in Global Regulatory Operations management team meetings. + Leads major Global Regulatory Affairs project teams. + Develop functional SOPs as well ... meet company goals. Has the ability to inspire and lead teams to fullest potential in a positive approach...Stock Purchase Plan and Tuition Assistance. **Reports To** VP Global Regulatory Affairs **Already Working… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Director, Global Regulatory Affairs , is a strategic role that will be ... Director, Regulatory Affairs , Strategy - Innovative Medicine (West...products. + As a global or regional lead within a global regulatory team,… more
- CSL Behring (King Of Prussia, PA)
- …after commercialization. + Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input ... Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in...with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) ( Global … more
- Pfizer (Collegeville, PA)
- …in Inflammation and Immunology specific therapeutic areas + Demonstrated ability to develop, lead and execute global medical affairs strategies and tactics, ... effectively benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead...Medical Director - Abrocitinib Team Lead will lead a team of medical affairs colleagues… more
- Organon & Co. (Plymouth Meeting, PA)
- …products through the product lifecycle. + Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of ... CMC changes, identification of global regulatory requirements, and critical evaluation of...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Pfizer (Collegeville, PA)
- The Global Clinical Lead is a leadership role that represents clinical development on the Medicine Team as the single point of accountability for clinical ... assets for heart failure and other cardiovascular indications. + Leads the Global Clinical Team towards the common goal of approvable worldwide regulatory… more
- Pfizer (Collegeville, PA)
- …and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs ... willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires… more
- IFF (Wilmington, DE)
- …in home and personal care-and beyond. Our Chemical Substance Registration Team, part of Global Regulatory Affairs (GRA), is growing, and we are looking ... enzyme, and polysaccharide products. This includes working closely with the DEB Global Regulatory Strategy Leader (GRSL), the Product Safety Group and… more
- Pfizer (Collegeville, PA)
- **ROLE SUMMARY** The Global Product Counsel ("GPC") will serve as counsel for prescription product(s) across one or more businesses within Pfizer's Primary Care, ... counsel, including risk counselor, for assigned in-line and pipeline products on a global basis, as well as assigned business teams, along with other related legal… more
- Pfizer (Collegeville, PA)
- …will work with leaders from other CMAO functions, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, HV&E , ... experience; or + BS + 20 Yrs relevant experience Global Regulatory affairs , Pharma QMS...and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's… more
- Organon & Co. (Plymouth Meeting, PA)
- …Officer, working directly with the US Federal and State Policy and Government Affairs teams, the Global Policy team, the US Commercial organization, Organon ... cross-functional projects that are relevant to the US Government Affairs team and beyond. The Director will lead...to draft formal comments related to federal and state regulatory action. Develop public policy positions and cover policy… more
- Pfizer (Collegeville, PA)
- …Trial Manager, Site Excellence Partners, Site Relationship Partners, Site Care Partners, Contracts Lead , Regulatory Affairs , pCRO and others as required to ... hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory , Medical Affairs colleagues and other key...Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy… more
- Pfizer (Collegeville, PA)
- …and implementation of new ways of working and plans across the Medical Affairs organization, including Global Platforms, Categories, and Regional Medical Leads. ... with the Change Management Team Lead , Operational & Change Excellence Lead and Medical Affairs leads/colleagues. **ROLE RESPONSIBILITIES** + Develop and… more
- Organon & Co. (Plymouth Meeting, PA)
- …aiming to efficiently generate evidence that allows internal decision making, supports global registration with regulatory agencies and other health authorities, ... and is accountable for: + The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data Sciences (CDS)… more
- ThermoFisher Scientific (Philadelphia, PA)
- …be the primary point of contact providing advice, mentorship, and contractual and regulatory interpretation! The individual will lead and expand the healthcare ... risk by partnering with the relevant functional areas (finance marketing, medical affairs , regulatory ) to craft, coordinate, and embed relevant controls into… more
- Organon & Co. (Plymouth Meeting, PA)
- …coordination activities that interface with key internal stakeholders, including Medical Affairs , Sales, Marketing, HCP Engagement, Compliance and Regulatory . ... collaboration skills, including cross-divisionally with colleagues from Sales, Medical Affairs /Clinical, Compliance/Quality, and Regulatory . + Experience working… more
