Regulatory Site Officer

Sanofi•Swiftwater, PA

3d•Hybrid

About The Position

The 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. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Requirements

Bachelor's Degree
3 + years' experience in regulatory affairs, change control or technical writing OR 10 years in GxP regulated fields
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

Nice To Haves

Experience working with a Health Authority is helpful but not essential

Responsibilities

Supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater.
Manages change control assessments and regulatory activities linked to change controls for the site, including the update of CMC files.
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.