- Sumitomo Pharma (Albany, NY)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Grifols Shared Services North America, Inc (Manhattan, NY)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- Publicis Groupe (New York, NY)
- …The Senior Associate, Regulatory Review is responsible for ensuring regulatory submissions follow the protocols established by our pharmaceutical and ... of organization and attention to detail are required to ensure submissions are correct and error-free. **Responsibilities** **Core Duties and Responsibilities** +… more
- United Therapeutics (Albany, NY)
- …managing documentation and timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are ... the ESG portal + Proven track record in successfully navigating regulatory submissions + Proven ability to lead and influence data-driven strategy planning… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ Lead all aspects of the completeness and accuracy of information provided in regulatory submissions . + Lead and advise the planning, preparation and submission ... teams on the content, format, style architecture and timing of regulatory submissions . + Evaluate applications and conformance with the regulatory … more
- Danaher Corporation (Cortland, NY)
- …for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions , negotiate the resolution of agency questions, and secure ... (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory Compliance JOB SUMMARY Interprets federal/state/international regulations as they… more
- Citigroup (Getzville, NY)
- …audit reviews, provide supporting documentation to support reported values related to regulatory report submissions + Develop and execute plans, policies and ... The Regulatory Analytics Senior Analyst is an SVP level position, part of the Regulatory and Analytics function within Enterprise Data Office, the SVP will be… more
- Citigroup (Getzville, NY)
- …audit reviews, provide supporting documentation to support reported values related to regulatory report submissions + Develop and execute plans, policies and ... The Regulatory Analytics Analyst is a VP level position, part of the Regulatory and Analytics function within Enterprise Data Office, the VP will be supporting … more
- LSI Solutions (Victor, NY)
- …necessary regulatory documentation. + Prepare attachments and hyperlinks for submissions to regulatory agencies, notified body, competent authorities, and/or ... that skillset and branch out into the area of regulatory . We are seeking a person who is highly...all US/EU/CA requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical… more
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