Senior Manager, Regulatory Science, Policy, and Intelligence

CSL.com

Office

PA, King of Prussia, CSL Behring, United States

Full Time

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 Senior Manager, Regulatory Science? 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 Head of Global Regulatory Science and Policy.

Position Description Summary

The primary purpose of this role is to lead the advancement of regulatory and safety intelligence. This will be achieved in close collaboration with the Head of Global Regulatory Policy and Intelligence, GRASP, internal global regulatory and safety teams, and Competitive Intelligence (CI) team. The incumbent will monitor and analyze regulatory and safety trends, changes, and developments to inform strategic decision-making and maintain a competitive edge for CSL. The scope of this role is intentionally broad and may evolve over time in response to shifting business priorities and emerging opportunities.

Main Responsibilities & Accountabilities

•Regulatory Intelligence

Monitor, track, and analyze global regulatory changes, guidelines, and trends affecting drug development, approval, and post-marketing requirements.

Maintain and update a regulatory intelligence database with timely and accurate information. Provide strategic insights and risk assessments to internal stakeholders based on evolving regulatory landscapes. Collaborate with cross-functional teams to ensure regulatory strategies align with current and emerging requirements.

•Safety and Pharmacovigilance Intelligence

Monitor, track and analyze global PV regulations, safety reporting requirements, and risk management guidelines. Maintain and update safety intelligence database with timely and accurate information. Support the development and maintenance of PV systems and processes in compliance with international standards (ICH, EMA, FDA).

•Cross-functional Collaboration

Liaise with GRAS, clinical, medical affairs, and quality assurance teams to ensure alignment on compliance and safety strategies. Participate in internal audits and inspections by regulatory authorities.

•Vendor Management

Develop and nurture relationships with external vendors.

Qualifications & Experience Requirements

•BS degree in Life Sciences, Medical Science, Pharmacy, or a related field; graduate degree (PharmD, MD, PhD) are preferred.•Minimum of 6 years of experience in the life sciences industry, with exposure to regulatory affairs or a related function.•Strong analytical, data interpretation, and trend identification skills.•Proficiency in Microsoft Excel, PowerPoint, and other tools used for data presentation and analysis.•Proficiency with digital tools such as ChatGPT and Microsoft Copilot, along with a strong understanding of current AI trends, is preferred.•Understanding of regulatory and safety requirements across product development, post-marketing phases; prior regulatory experience is preferred.•Familiarity with US and EU regulatory and safety systems; additional global exposure is an advantage.•Experience contributing to regulatory and safety intelligence or policy work is beneficial.•Previous interaction with regulatory agencies such as FDA or EMA is a plus.•Strong communication skills in English, both written and verbal, with the ability to present information clearly and concisely.•Collaborative mindset, with the ability to build effective working relationships and networks.•Proactive, adaptable, and comfortable working in a cross-functional, multicultural environment.•Willingness to travel internationally up to 20% of the time.#LI-HYBRID

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!