What are the responsibilities and job description for the Regulatory Compliance Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- The Regulatory Compliance Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines projects.
- The focus of this position will be to support a Veeva Vault Rim project requiring previous regulatory and Veeva 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 Regulatory Compliance 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. Standard Operating Procedures, Site Master File, Product License Commitments).
- The Regulatory Compliance 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 proper assessment of change controls.
- The Regulatory Compliance 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 Regulatory Compliance Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
- The Regulatory Compliance Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required and serve as the Regulatory interface between M&S, MSAT and GRA.
- Bachelor's Degree/Undergraduate Degree. Experience in pharmaceutical/biopharmaceutical industry or related regulatory, industry/manufacturing environment.
- Well-developed communication skills, both verbal and written. Years of Experience: 2 - 6 Years.
- Previous Veeva 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 efficiently.
- Ability to resolve strategic technical and regulatory issues.
- Should demonstrate initiative, analytical thinking and works independently.
- Ability to work well with cross functional teams, and good communication skills with internal and external 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.