Alexander Mann Solutions (AMS) is the world's leading provider of Talent Acquisition and Management Services. We deliver award-winning solutions to over 65 outsourcing clients and consulting services to hundreds more. Our Contingent Workforce Solutions (CWS) service acts as an extension of our clients' recruitment team and provides professional interim and temporary resources.
Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.
On behalf of this organisation, AMS are looking for a Regulatory Affairs Officer for a 12 month contract based in Waterford,Ireland.
Purpose of Role
- To manage regulatory issues locally at site, supporting improved compliance and regulatory awareness.
- To ensure that only Products meeting all appropriate testing and release criteria are released to market.
- To act as liaison with regulatory authorities, supporting new product and variation approvals.
- Support & maintain Waterford's regulatory filings.
- Oversees the day to day management of RA systems, directing the workload of the RA Team
- Provides regulatory advice (US, EU etc.) and support to the Waterford site, facilitating the introduction of new products, process technologies and continuous improvement projects.
- Review and approval of appropriate documents e.g. PMF, SMF
- Evaluate the regulatory impact of proposed changes at the sites
- Communicate proposed CMC changes for prioritisation as necessary
- Maintain regulatory documents such as Site Master Files. Co-ordinate preparation of Product Quality Reviews and Annual Reports (US market).
- Represent Waterford site at global Regulatory Affairs meetings as required
- Ensure the appropriate involvement of corporate RA-CMC personnel as necessary
- Ensure appropriate personnel at all sites impacted are notified following Regulatory Authority approvals, indicating when approved variations may be implemented.
- Ensure, via corporate RA-CMC, that compliance is not compromised between country requirements and actual site practices
- Maintain complete copies of CMC documents submitted to and approved by Regulatory Authorities
Compliance Related Tasks
- Ensure only product meeting all applicable regulatory requirements are released to market.
- Competent at dealing with regulatory authorities in EU, US and/or similar markets.
- Thorough understanding of EU and US regulatory requirements
- Ability to write/review technical regulatory sections of relevant CMC documentation.
- Demonstrated ability to effectively manage all aspects of regulatory projects
- Serve as a resource and provide intelligence on current requirements and new local regulatory developments to RAUS to ensure Corporate and regional regulatory strategies adequately address the changing regulatory environment and prepare for local demands
- Ensure compliance to cGMP at all times
- Degree in Science, Pharmacy or related discipline essential.
- Post Graduate Studies as appropriate to augment Primary Degree.
- Eligibility to act as Qualified Person an advantage
- At least 3-4 years' experience in a similar role, working with international regulatory authorities
- Experience of manufacturing operations, dealing with regulatory authorities, and working through Corporate structures highly desirable
- CMC Regulatory Experience
If you are interested in applying for this position and meet the criteria outlined above, please click the link to apply and speak to one of our sourcing specialists now.