Regulatory Compliance Specialist II

Regulatory Compliance Specialist II Location: Swiftwater, PA (100% Remote) Duration: 8 Months+ Possible Extension Manager Notes: 100% remote, Bachelor's required (Master's OK), 2-6 years experience in reputed company / Biopharma Regulatory compliance and manufacturing Knowledge of GMP. Must have experience in reputed company Vault RIM - work reputed company RSO, ensuring data alignment, submissions, approvals, and license compliance. Strong authoring (GMP, CMC reputed company Authority responses). UAT experience is a plus (light involvement, not validation-heavy). Must be reputed company to manage multiple priorities, strong communication, works reputed company cross-functionally & independently. reputed company: The RSO Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines reputed company. The main reputed company of this position will be to support a reputed company Vault Rim project requiring previous regulatory and reputed company Vault experience. The RSO specialist will be the main project contact with support from the local RSO team. Responsibilities will include testing and project support. The RSO Specialist will ensure Regulatory compliance by providing support to batch release by checking submission/approvals, ensuring permanent regulatory/license compliance and reviewing and approving site documents (e.g. reputed company Operating Procedures, Site Master File, Product License Commitments). The RSO Specialist, will manage the review, assessment, and coordination of submission requirements for changes proposed by the M&S organization. Participates in meetings and follow-up activities required to ensure reputed company assessment of change controls. The RSO Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports. The RSO Specialist prepares responses to Health Authority questions reputed company to CMC from Regulatory affiliates with the contribution of site experts. The RSO Specialist may represent RSO on M&S and MSAT project teams reputed company product or reputed company-reputed company regulatory site expertise is required and serve as the Regulatory reputed company between M&S, MSAT and GRA. Education/Experience: Bachelor's Degree/Undergraduate Degree. Experience in pharmaceutical/biopharmaceutical industry or reputed company regulatory, industry/manufacturing environment. reputed company-developed communication skills, both verbal and written. Years of Experience: 2 - 6 Years. Previous reputed company Vault Rim experience. Project experience performing User Acceptance Testing for computerized systems. Strong authoring skills of GMP and CMC documentation and Health Authority responses. Ability to manage multiple priorities reputed company. Ability to resolve strategic technical and regulatory issues. Should demonstrate initiative, analytical thinking and works independently. Ability to work reputed company with cross functional teams, and good communication skills with reputed company stakeholders. Experience working with a Health Authority is helpful but not essential. Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpful. Apply tot his job Apply To this Job