Job Title: Regulatory Site OfficerAbout the JobThe Regulatory Site Office, Vaccines will work closely with the Manufacturing and Supply teams and CMC colleagues on Vaccines based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations. The RSO management and position are based in Swiftwater, PA USA. This is a hybrid position.
Main ResponsibilitiesThe RSO within the Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. The incumbent manages change control assessments and regulatory activities linked to change controls for the site, including the update of CMC files. These accountabilities include:
- Change Control Assessments
- PLC Management
- Authoring the variations, the CTD sections impacted by the changes, and the renewals of the site products registrations, in compliance with all applicable regulations and company processes
- Maintaining and updating regulatory files and databases
- Defining the potential regulatory impacts of changes made to the site products and services
- Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates
- Assisting in internal and external audits, including regulatory inspections
About YouBasic Qualifications- Bachelor's Degree
- 3 + years' experience in regulatory affairs, change control or technical writing
- OR 10 years in GxP regulated fields
Other Qualifications- Experience with regulatory preparation of CMC dossier
- Well-developed communication skills, both verbal and written
- In-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industry
- Ability to analyze complex regulatory documents and data to ensure compliance and identify potential issues
- Demonstrates initiative, analytical thinking and works independently
- Proficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and compliance
- High level of accuracy and attention to detail in preparing and reviewing regulatory documents and reports
- Experience working with a Health Authority is helpful but not essential
Why choose us?- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
The salary range for this position is:
$90,000.00 - $130,000.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
