GRA CMC Specialist at CSL

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jun, 26

Salary

0.0

Posted On

01 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Project Management, Relationship Management, Documentation, Data Entry, Regulatory Compliance, Pharmaceutical Industry, Biologics, Communication, Planning, Monitoring, Advising, Legal Preparation, Cost Estimation, Schedule Development, Government Relations

Industry

Pharmaceutical Manufacturing

Description

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. Qualifications: • Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage. • 3+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates

Responsibilities

The GRA CMC Specialist will plan, direct, and monitor regulatory affairs activities to ensure the organization has the necessary approvals for business operations. They will also establish relationships with regulatory authorities and represent the organization in regulatory matters.