GRA CMC Specialist

CSL • Waltham, MA

1d

About The Position

CSL Behring is a global biotherapeutics leader dedicated to saving lives by leveraging the latest technologies to discover, develop, and deliver innovative therapies. The company focuses on patients with conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. CSL Behring employs three strategic scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy, to address unmet medical needs and help patients lead full lives. CSL Behring operates CSL Plasma, one of the world’s largest plasma collection networks. Its parent company, CSL, is headquartered in Melbourne, Australia, employs 32,000 people, and delivers its therapies to over 100 countries. CSL is committed to Inclusion and Belonging, fostering a culture of curiosity and empathy to better understand and connect with patients and donors, build strong stakeholder relationships, and maintain a diverse workforce for the future.

Requirements

• Bachelor degree in a Life Science or Business
• 3+ years regulatory experience in the pharmaceutical industry.

Nice To Haves

• Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage.
• Biologics Regulatory experience preferred.

Responsibilities

• Plan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals needed to conduct current and future business activities; and produce, sell, and distribute its goods and services.
• Support development of consistent roles and work processes.
• Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvals.
• Monitor regulatory developments and advise management on the potential impact of regulations on the organization.
• Establish and maintain positive relationships with government agencies and other regulatory authorities.
• Represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization's interests are advanced.
• Prepare materials for legal counsel or external consultants.
• Create and compile of registration application documentation.
• Regulatory system, data entry and maintenance in/of regulatory systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level