GRA CMC Specialist

CSL Plasma•Waltham, MA

About The Position

GRA CMC Specialist will plan, support, and monitor regulatory affairs activities related to plasma derived medicinal products and human plasma as starting material to ensure compliance with global regulatory requirements and support current and future business activities. This role will support the preparation, review, and maintenance of regulatory documentation for Plasma Master Files (PMFs), plasma source registrations, and related submissions for the European Union, Switzerland, and international markets. The specialist will also support the preparation and submission of regulatory applications, variations, renewals, responses to health authority questions, and other regulatory filings related to plasma and biologic products. Additionally, the role contributes to the assessment and implementation of regulatory requirements, guidelines, and emerging regulations impacting plasma derived products, plasma collection, and related manufacturing processes. The specialist will support regulatory activities associated with plasma source lifecycle management, including new plasma source registrations, maintenance activities, and change control assessments. Collaboration with cross-functional teams is essential to support regulatory strategy development, change management activities, technical assessments, and regulatory risk evaluations. The role also supports interactions with global regulatory authorities and contributes to the preparation of health authority communications, briefing materials, and scientific or regulatory discussions. Support is provided for regulatory activities associated with U.S. plasma center licensing and maintenance activities, including coordination of documentation and support for regulatory inspections and submissions. The specialist contributes to scientific and technical regulatory evaluations related to plasma collection, plasma manufacturing processes, and biologic product lifecycle management. Monitoring regulatory developments and advising management and project teams on the potential impact of new or changing regulations on business activities and regulatory strategies is a key function. Establishing and maintaining effective working relationships with internal stakeholders, regulatory agencies, and external partners is crucial. Support for the development of consistent roles, work processes, regulatory procedures, and documentation practices across global regulatory activities is also expected. Finally, the role involves regulatory system data entry, maintenance, and management of regulatory information and documentation within applicable systems.

Requirements

Bachelor degree in a Life Science or related scientific discipline required.
3+ years regulatory experience in the pharmaceutical, biologics, or biotechnology industry.
Strong scientific, analytical, communication, and organizational skills with the ability to manage multiple projects and priorities in a global environment.
Ability to work collaboratively across functions and contribute to complex regulatory and technical discussions.

Nice To Haves

Advanced degree in a Life Science (PhD, MD) or Regulatory Affairs related field an advantage.
Experience with biologics, plasma derived medicinal products, or blood/plasma related regulations preferred.
Experience supporting global regulatory submissions and interactions with regulatory authorities preferred.

Responsibilities

Plan, support, and monitor regulatory affairs activities related to plasma derived medicinal products and human plasma as starting material to ensure compliance with global regulatory requirements and support current and future business activities.
Support the preparation, review, and maintenance of regulatory documentation for Plasma Master Files (PMFs), plasma source registrations, and related submissions for the European Union, Switzerland, and international markets.
Support preparation and submission of regulatory applications, variations, renewals, responses to health authority questions, and other regulatory filings related to plasma and biologic products.
Contribute to the assessment and implementation of regulatory requirements, guidelines, and emerging regulations impacting plasma derived products, plasma collection, and related manufacturing processes.
Support regulatory activities associated with plasma source lifecycle management, including new plasma source registrations, maintenance activities, and change control assessments.
Collaborate with cross functional teams to support regulatory strategy development, change management activities, technical assessments, and regulatory risk evaluations.
Support interactions with global regulatory authorities and contribute to the preparation of health authority communications, briefing materials, and scientific or regulatory discussions.
Support regulatory activities associated with U.S. plasma center licensing and maintenance activities, including coordination of documentation and support for regulatory inspections and submissions.
Contribute to scientific and technical regulatory evaluations related to plasma collection, plasma manufacturing processes, and biologic product lifecycle management.
Monitor regulatory developments and advise management and project teams on the potential impact of new or changing regulations on business activities and regulatory strategies.
Establish and maintain effective working relationships with internal stakeholders, regulatory agencies, and external partners.
Support development of consistent roles, work processes, regulatory procedures, and documentation practices across global regulatory activities.
Regulatory system data entry, maintenance, and management of regulatory information and documentation within applicable systems.