Regulatory Coordinator - US
Job Description
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Regulatory Coordinator? The job is in our King of Prussia, PA office. This is a hybrid position and is onsite three days a week. You will report to the Executive Director Head Regulatory.
Position Description Summary
•Driving the planning and execution of internal GRAS processes for regulatory activities (e.g. submission, document preparation / compilation, etc.) as requested by GRS team members. Proactively communicates status of activities to requesting team members and as needed, managers.
•Proactively supports receipt and distribution of health authority communications and updates to respective Regulatory Information Management Systems (RIMS) (e.g. Veeva). Takes the lead to ensure timelines are met and reports respective Key Performance Indicators (KPIs).
•In support of a GRL / GRAST Member, may generate, edit, compile and/or format documentation as time permits, as well as other GRAST deliverables.
•Effectively partner with Global Regulatory Strategy Leaders Team (GRSLT) to support conduct and report outcomes from LT, GRS group, team and face-to-face meetings. May support logistical activities for LT members as designated.
Main Responsibilities & Accountabilities
•Acts as support for full GRS team for designated processes/activities within assigned region and can assume tactical execution of activities as assigned from a GRL / RRS or RRL.
•Developing expertise with automation and artificial intelligence tools to facilitate assigned activities and be a resource for the full GRS team. Maintains internal GRS team / Sharepoint sites.
•Acts as departmental expert for RIMS (e.g. Veeva) and supports troubleshooting with respective RRS and RRLs in respective region. May specialize in additional systems (e.g. Clarity, Ariba, Concur, SurveyMonkey, etc.) as requested by GRSLT. Supports onboarding of GRS team members in region.
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•Proactively fosters and promotes effective relationships across Global Regulatory Strategy.
•Applies the CSL Leadership Capabilities - Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent - to oneself.
Qualifications & Experience Requirements
•A bachelor's degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is preferred. Relevant professional experience (minimum 7+ years) may be utilized in lieu of the degree requirement.
•Minimum of 3 years' experience in the biotech or pharmaceutical industry. Previous regulatory affairs experience is preferred.
•Experience in working in teams with team members located at site and overseas.
•Preferred candidates have developing knowledge and understanding of pharmaceutical/biological product development activities.
•Experience with respective corporate systems and automation / artificial intelligence is preferred. Veeva experience is a preferred.
•Relevant experience working in a complex and matrix environment is preferred.
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Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
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.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Perks and Benefits
Health and Wellness
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- FSA
- HSA
- Mental Health Benefits
Parental Benefits
- Adoption Leave
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
Work Flexibility
Office Life and Perks
- Commuter Benefits Program
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
- Leave of Absence
- Volunteer Time Off
Financial and Retirement
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Tuition Reimbursement
Diversity and Inclusion