job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Waltham, Massachusetts
job type: Contract
salary: $39.39 - 46.34 per hour
work hours: 9 to 5
- Work with the project teams to determine the approach for complex maintenance of Dossier Compliance and State of-the-Art compliance projects.
- Ensure that changes affecting more than one site are evaluated and approved through the multi-site change control process.
- Perform gap analysis of technical documents and determine interrelated impacts to process and systems.
- Ensure completeness and correctness of items such as engineering studies, validation studies, technical reports, engineering drawings and MBRs/SOPs.
- Manage regulatory issues locally at site, supporting improved compliance and regulatory awareness.
- Evaluate the regulatory impact of proposed changes at the sites
- Communicate proposed CMC changes for prioritization as necessary to ensure that only Products meeting all the license requirements are released to market
- Assist in maintaining regulatory documents such as Site Master Files. Coordinate preparation of Product Quality Reviews and Annual Reports (US market) to ensure that only products meeting all appropriate testing and release criteria are released to market
- Act as liaison with regulatory authorities, supporting new product and variation approvals
- Help support & maintain regulatory filings Provide regulatory advice (US, EU etc.) and support to the site, facilitating the introduction of new products, process technologies and continuous improvement projects.
- Work independently with little or no supervision and exercises considerable discretion in determining objectives and approaches to significant organizational projects or assignments and employees
- Bachelor's degree with scientific background or equivalent and 5+ years of experience in a GxP or regulatory affairs environment. OR Master's degree with scientific background and 5 years of experience in a GxP or regulatory affairs environment, to include 5 years in a regulatory affairs role.
- Years of Experience: 3 - 6 Years
skills: FDA, Regulatory Affairs Operations, Regulatory Briefing Documents
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.