- Parexel (Harrisburg, PA)
- **Join Parexel as a Regulatory Affairs Strategy Lead ** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be...key liaison with Health Authorities. What You'll Do - Lead regulatory strategy for assigned programs from… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to agency questions… more
- System One (Pittsburgh, PA)
- Job Title: Regulatory Affairs Lead , IND /IDE Location: Remote Schedule: Standard business hours and M-F Type: 12-month Contract to Hire Hourly rate: ... $41-$46 an hr Overview: Our client is seeking a Regulatory Affairs Lead , IND /IDE. This senior position provides end-to-end regulatory strategy and… more
- Parexel (Harrisburg, PA)
- **Join Parexel as a Regulatory Affairs Strategy Lead ** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be...key liaison with Health Authorities. What You'll Do * Lead regulatory strategy for assigned programs from… more
- Sumitomo Pharma (Harrisburg, PA)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an...advertising and promotion of prescription drugs + Guide and/or lead regulatory agency interactions, including communications and… more
- Bausch + Lomb (Harrisburg, PA)
- …diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND , NDA, ANDA, and BLA submissions. + Plan, author, ... the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more
- Bausch + Lomb (Harrisburg, PA)
- …across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND , NDA and ANDA submissions and OTC products and ... PAS, group supplements, site transfers, and supplier changes) for IND , NDA, ANDA amendments/supplements + Review raw materials and...Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer… more
- United Therapeutics (Harrisburg, PA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...ESG portal + Proven track record in successfully navigating regulatory submissions + Proven ability to lead … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an ... regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- University of Pennsylvania (Philadelphia, PA)
- …roles and responsibilities of sponsors, vendors, clinical researchers, and government officials. Regulatory Affairs Specialist C will lead the coordination ... research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist C is expected to lead the development of unit… more
- University of Pennsylvania (Philadelphia, PA)
- …subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating ... to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and essential… more
- Pfizer (Collegeville, PA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... **POSITION SUMMARY** You will lead and coordinate the development of multiple studies...study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds… more
- Teva Pharmaceuticals (West Chester, PA)
- …container closure integrity analytical test methods. * Interface with Human Factors, Regulatory Affairs , and external partners for technical alignment. ... injectors, and other delivery systems for biologics. You will lead root cause investigations into issues such as out-of-trend...conditions. * Track record of authoring technical content in regulatory submissions ( IND , BLA, MAA). **Enjoy a… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards. Job Description Job Responsibilities Clinical Research Nurse C Responsibilities ... + This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to supervisor. + Work directly with physicians to… more
