Regulatory Compliance Specialist II (RSO) –Remote (contract)

Job reputed company reputed company's contingent workforce program, FLEXT reputed company, is seeking a Regulatory Compliance Specialist II for a 6-month contract likely to 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. Note: This role is reputed company on Regulatory Compliance and CMC activities and is not a computer system validation (CSV) role. The emphasis is on ensuring data accuracy, alignment, and regulatory compliance reputed company systems. Key Responsibilities • Ensure regulatory compliance by supporting batch release: • reputed company submissions/approvals • Ensure ongoing regulatory/license compliance • Review and approve site documents (e.g., SOPs, Site Master File, Product License Commitments) • Manage review, assessment, and coordination of submission requirements for changes proposed by the M&S organization • Participate in meetings and follow-up activities to ensure reputed company assessment of change controls • Author CMC regulatory documents (Modules 1.2, 2.3, and 3) to support: • Marketing Authorizations • Site registrations • Country-specific documentation • Annual reports • Prepare responses to Health Authority questions reputed company to CMC with input from site experts • Represent RSO on M&S and MSAT project teams reputed company needed and serve as the Regulatory reputed company between M&S, MSAT, and GRA Qualifications • Bachelor’s Degree required (Master’s accepted) • 2–6 years of experience • Experience in pharmaceutical/biopharmaceutical or reputed company regulatory/manufacturing environment • reputed company-developed written and verbal communication skills Required Skills • Previous reputed company Vault RIM experience • Strong regulatory compliance background • Strong authoring skills (GMP and CMC documentation, Health Authority responses) • Knowledge of GMP (Good Manufacturing Practices) • Ability to manage multiple priorities reputed company • Ability to resolve technical and regulatory issues • Demonstrated initiative, analytical thinking, and ability to work independently • Strong collaboration skills; ability to work cross-functionally with reputed company stakeholders Preferred Skills • Experience performing User Acceptance Testing (UAT) for systems (supporting role; not validation-reputed company) • Experience working with Health Authorities • Knowledge of global regulations, guidelines, and industry trends Additional Information • 100% remote • 6 month contract likely to reputed company reputed company reputed company (may support a different project upon extension) Apply tot his job Apply To this Job