GRA CMC Global PMF Lead at CSL

São José da Laje, Alagoas, Brazil -

Full Time

Start Date

Immediate

Expiry Date

30 Jun, 26

Salary

0.0

Posted On

01 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Activities, Product Strategies, Leadership, Team Management, Regulatory Compliance, Biologics, FDA Regulations, EU Regulations, ICH Guidelines, Communication, Collaboration, Knowledge Sharing, Biological Regulations, Project Management, Stakeholder Engagement, Technology Adoption

Industry

Pharmaceutical Manufacturing

Description

Responsibilities: •Oversees and directs regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements regulatory product strategies. • Demonstrated familiarity with and ability to interpret the Code of Federal Regulations and other FDA, EU, CA, AU and ICH documents to prepare regulatory / product development strategies. • Establish team priorities, goals and objectives while monitoring development and execution of tactical work plans to accomplish goals and objectives. Coordinate intracompany activities to obtain and compile information for submission to Regulatory Agencies regarding licenses and registrations. • Interface directly with Regulatory bodies worldwide in obtaining product registration/licensure. • Implement programs and procedures necessary to achieve compliance with new regulatory requirements. Developing consistent roles and work processes across the team, fostering adoption of technology to further improve consistency and efficiency of overall team. • Maintain a strong collaborative relationship across the CSL sites. This includes site communications & knowledge sharing. Develop and maintain good working relationships with all stakeholders. • Maintain an intimate knowledge of biological regulations. Qualifications: • Advanced degree in a Life Science or Business (Master, PhD, MBA). • 10+ years regulatory experience in the pharmaceutical industry, Biologics Regulatory experience preferred. • At least 5 years leadership experience. 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

Oversees and directs regulatory activities for new and mature products to ensure compliance with registration requirements. Establishes team priorities and coordinates activities for submission to regulatory agencies.